NCT01807221 (ARTS-HF) is a Phase 2 clinical trial of Finerenone (BAY94-8862) in Heart Failure, sponsored by Bayer.

Who is sponsoring NCT01807221?

NCT01807221 is sponsored by Bayer.

What drugs are being tested in NCT01807221?

Interventions in NCT01807221: Finerenone (BAY94-8862), Placebo, Inspra (eplerenone).

What condition does NCT01807221 study?

NCT01807221 studies Heart Failure.

Is NCT01807221 still recruiting?

NCT01807221 is currently completed. Last updated 6 July 2021.

Are results published for NCT01807221?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-07-06 · How we verify

NCT01807221: ARTS-HF

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone

Completed Phase 2 Results posted Last updated 6 July 2021

What this trial tests

Phase 2 trial testing Finerenone (BAY94-8862) in Heart Failure in 1,066 participants. Completed in 9 December 2014.

Timeline

17 June 2013

Primary endpoint
11 November 2014

9 December 2014

Quick facts

Lead sponsor	Bayer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,066
Start date	17 June 2013
Primary completion	11 November 2014
Estimated completion	9 December 2014
Sites	172 locations across Italy, Finland, Taiwan, Poland, South Korea, Denmark, Netherlands, Sweden

Drugs / interventions tested

Finerenone (BAY94-8862) — full drug profile →
Placebo
Inspra (eplerenone) — full drug profile →

Conditions studied

Heart Failure — all drugs for Heart Failure →

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90 Primary · Baseline and Day 90

N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute and chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.

Group	Value	95% CI
Eplerenone (INSPRA®)	37.2	31.6 – 43.1
Finerenone (BAY94-8862) 2.5-5 mg OD	30.9	24.9 – 37.4
Finerenone (BAY94-8862) 5-10 mg OD	32.5	26.3 – 39.2
Finerenone (BAY94-8862) 7.5-15 mg OD	37.3	30.9 – 44.1
Finerenone (BAY94-8862) 10-20 mg OD	38.8	32.3 – 45.5
Finerenone (BAY94-8862) 15-20 mg OD	34.2	27.9 – 40.9

Number of Participants With Death Due to Any Cause Secondary · Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)

Death due to any cause include cardiovascular (CV) death and Non-CV death. Non-CV death was classified by 2 subcategories: non-malignant causes and malignant causes.

Day 30

Group	Value	95% CI
Eplerenone (INSPRA®)	6
Finerenone (BAY94-8862) 2.5-5 mg OD	5
Finerenone (BAY94-8862) 5-10 mg OD	1
Finerenone (BAY94-8862) 7.5-15 mg OD	1
Finerenone (BAY94-8862) 10-20 mg OD	0
Finerenone (BAY94-8862) 15-20 mg OD	2

Day 60

Group	Value	95% CI
Eplerenone (INSPRA®)	7
Finerenone (BAY94-8862) 2.5-5 mg OD	7
Finerenone (BAY94-8862) 5-10 mg OD	3
Finerenone (BAY94-8862) 7.5-15 mg OD	2
Finerenone (BAY94-8862) 10-20 mg OD	0
Finerenone (BAY94-8862) 15-20 mg OD	4

Day 90

Group	Value	95% CI
Eplerenone (INSPRA®)	9
Finerenone (BAY94-8862) 2.5-5 mg OD	10
Finerenone (BAY94-8862) 5-10 mg OD	4
Finerenone (BAY94-8862) 7.5-15 mg OD	4
Finerenone (BAY94-8862) 10-20 mg OD	1
Finerenone (BAY94-8862) 15-20 mg OD	5

Follow-up

Group	Value	95% CI
Eplerenone (INSPRA®)	15
Finerenone (BAY94-8862) 2.5-5 mg OD	16
Finerenone (BAY94-8862) 5-10 mg OD	7
Finerenone (BAY94-8862) 7.5-15 mg OD	11
Finerenone (BAY94-8862) 10-20 mg OD	2
Finerenone (BAY94-8862) 15-20 mg OD	8

Number of Participants With Cardiovascular Hospitalization Secondary · Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)

Hospitalizations were defined as any unplanned admission to hospital, i.e. completion of hospital admission procedures and one overnight \[i.e. date change\] stay or until the death of subject occurred. Hospitalizations and deaths were classified by 2 primary categories: CV and non-CV. The pre-specified subcategories for CV hospitalizations were as follows: 1. Worsening heart failure, 2.Acute myocardial infarction, 3. Arrhythmia, 4.Transient ischemic attack and stroke, 5. Other CV hospitalizations.

Day 30

Group	Value	95% CI
Eplerenone (INSPRA®)	28
Finerenone (BAY94-8862) 2.5-5 mg OD	23
Finerenone (BAY94-8862) 5-10 mg OD	14
Finerenone (BAY94-8862) 7.5-15 mg OD	8
Finerenone (BAY94-8862) 10-20 mg OD	7
Finerenone (BAY94-8862) 15-20 mg OD	15

Day 60

Group	Value	95% CI
Eplerenone (INSPRA®)	43
Finerenone (BAY94-8862) 2.5-5 mg OD	33
Finerenone (BAY94-8862) 5-10 mg OD	23
Finerenone (BAY94-8862) 7.5-15 mg OD	21
Finerenone (BAY94-8862) 10-20 mg OD	15
Finerenone (BAY94-8862) 15-20 mg OD	23

Day 90

Group	Value	95% CI
Eplerenone (INSPRA®)	45
Finerenone (BAY94-8862) 2.5-5 mg OD	35
Finerenone (BAY94-8862) 5-10 mg OD	26
Finerenone (BAY94-8862) 7.5-15 mg OD	29
Finerenone (BAY94-8862) 10-20 mg OD	22
Finerenone (BAY94-8862) 15-20 mg OD	28

Follow-up

Group	Value	95% CI
Eplerenone (INSPRA®)	56
Finerenone (BAY94-8862) 2.5-5 mg OD	43
Finerenone (BAY94-8862) 5-10 mg OD	38
Finerenone (BAY94-8862) 7.5-15 mg OD	36
Finerenone (BAY94-8862) 10-20 mg OD	27
Finerenone (BAY94-8862) 15-20 mg OD	34

Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) Secondary · Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)

Emergency presentations for WCHF were defined as newly developing signs and symptoms of WCHF after start of treatment with study drug, requiring an additional emergency presentation to hospital and IV treatment with diuretics and/or positive inotropic agents.

Day 30

Group	Value	95% CI
Eplerenone (INSPRA®)	21
Finerenone (BAY94-8862) 2.5-5 mg OD	19
Finerenone (BAY94-8862) 5-10 mg OD	12
Finerenone (BAY94-8862) 7.5-15 mg OD	9
Finerenone (BAY94-8862) 10-20 mg OD	7
Finerenone (BAY94-8862) 15-20 mg OD	15

Day 60

Group	Value	95% CI
Eplerenone (INSPRA®)	35
Finerenone (BAY94-8862) 2.5-5 mg OD	30
Finerenone (BAY94-8862) 5-10 mg OD	20
Finerenone (BAY94-8862) 7.5-15 mg OD	17
Finerenone (BAY94-8862) 10-20 mg OD	14
Finerenone (BAY94-8862) 15-20 mg OD	22

Day 90

Group	Value	95% CI
Eplerenone (INSPRA®)	37
Finerenone (BAY94-8862) 2.5-5 mg OD	32
Finerenone (BAY94-8862) 5-10 mg OD	22
Finerenone (BAY94-8862) 7.5-15 mg OD	24
Finerenone (BAY94-8862) 10-20 mg OD	18
Finerenone (BAY94-8862) 15-20 mg OD	28

Follow-up

Group	Value	95% CI
Eplerenone (INSPRA®)	47
Finerenone (BAY94-8862) 2.5-5 mg OD	40
Finerenone (BAY94-8862) 5-10 mg OD	30
Finerenone (BAY94-8862) 7.5-15 mg OD	30
Finerenone (BAY94-8862) 10-20 mg OD	26
Finerenone (BAY94-8862) 15-20 mg OD	34

Ratio of BNP at Specified Visits to BNP at Baseline Secondary · Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

B-type natriuretic peptide (BNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.

Day 30

Group	Value	95% CI
Eplerenone (INSPRA®)	0.925	± 2.02
Finerenone (BAY94-8862) 2.5-5 mg OD	0.944	± 1.952
Finerenone (BAY94-8862) 5-10 mg OD	0.878	± 1.713
Finerenone (BAY94-8862) 7.5-15 mg OD	0.832	± 1.959
Finerenone (BAY94-8862) 10-20 mg OD	0.852	± 1.901
Finerenone (BAY94-8862) 15-20 mg OD	0.879	± 1.968

Day 60

Group	Value	95% CI
Eplerenone (INSPRA®)	0.783	± 2.194
Finerenone (BAY94-8862) 2.5-5 mg OD	0.864	± 2.139
Finerenone (BAY94-8862) 5-10 mg OD	0.854	± 1.854
Finerenone (BAY94-8862) 7.5-15 mg OD	0.79	± 2.179
Finerenone (BAY94-8862) 10-20 mg OD	0.711	± 2.116
Finerenone (BAY94-8862) 15-20 mg OD	0.824	± 2.142

Day 90

Group	Value	95% CI
Eplerenone (INSPRA®)	0.723	± 2.202
Finerenone (BAY94-8862) 2.5-5 mg OD	0.813	± 2.412
Finerenone (BAY94-8862) 5-10 mg OD	0.839	± 1.93
Finerenone (BAY94-8862) 7.5-15 mg OD	0.719	± 2.204
Finerenone (BAY94-8862) 10-20 mg OD	0.706	± 2.34
Finerenone (BAY94-8862) 15-20 mg OD	0.771	± 2.197

Premature discontinuation

Group	Value	95% CI
Eplerenone (INSPRA®)	0.896	± 0.896
Finerenone (BAY94-8862) 2.5-5 mg OD	1.104	± 2.15
Finerenone (BAY94-8862) 5-10 mg OD	1.006	± 2.422
Finerenone (BAY94-8862) 7.5-15 mg OD	0.884	± 1.973
Finerenone (BAY94-8862) 10-20 mg OD	0.848	± 2.218
Finerenone (BAY94-8862) 15-20 mg OD	1.044	± 2.174

Follow-up

Group	Value	95% CI
Eplerenone (INSPRA®)	0.795	± 2.232
Finerenone (BAY94-8862) 2.5-5 mg OD	0.815	± 2.388
Finerenone (BAY94-8862) 5-10 mg OD	0.886	± 2.199
Finerenone (BAY94-8862) 7.5-15 mg OD	0.726	± 2.397
Finerenone (BAY94-8862) 10-20 mg OD	0.729	± 2.487
Finerenone (BAY94-8862) 15-20 mg OD	0.852	± 2.169

Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline Secondary · Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.

Day 30

Group	Value	95% CI
Eplerenone (INSPRA®)	0.883	± 2.458
Finerenone (BAY94-8862) 2.5-5 mg OD	0.98	± 2.158
Finerenone (BAY94-8862) 5-10 mg OD	0.874	± 2.14
Finerenone (BAY94-8862) 7.5-15 mg OD	0.888	± 2.123
Finerenone (BAY94-8862) 10-20 mg OD	0.822	± 2.217
Finerenone (BAY94-8862) 15-20 mg OD	0.921	± 2.136

Day 60

Group	Value	95% CI
Eplerenone (INSPRA®)	0.749	± 2.73
Finerenone (BAY94-8862) 2.5-5 mg OD	0.822	± 2.423
Finerenone (BAY94-8862) 5-10 mg OD	0.814	± 2.178
Finerenone (BAY94-8862) 7.5-15 mg OD	0.81	± 2.268
Finerenone (BAY94-8862) 10-20 mg OD	0.748	± 2.496
Finerenone (BAY94-8862) 15-20 mg OD	0.829	± 2.288

Day 90

Group	Value	95% CI
Eplerenone (INSPRA®)	0.688	± 2.59
Finerenone (BAY94-8862) 2.5-5 mg OD	0.789	± 2.661
Finerenone (BAY94-8862) 5-10 mg OD	0.765	± 2.214
Finerenone (BAY94-8862) 7.5-15 mg OD	0.783	± 2.454
Finerenone (BAY94-8862) 10-20 mg OD	0.728	± 2.795
Finerenone (BAY94-8862) 15-20 mg OD	0.771	± 2.471

Premature discontinuation

Group	Value	95% CI
Eplerenone (INSPRA®)	0.948	± 2.684
Finerenone (BAY94-8862) 2.5-5 mg OD	1.369	± 2.087
Finerenone (BAY94-8862) 5-10 mg OD	1.267	± 2.261
Finerenone (BAY94-8862) 7.5-15 mg OD	0.927	± 1.864
Finerenone (BAY94-8862) 10-20 mg OD	1.133	± 2.981
Finerenone (BAY94-8862) 15-20 mg OD	0.965	± 2.352

Follow-up

Group	Value	95% CI
Eplerenone (INSPRA®)	0.747	± 2.616
Finerenone (BAY94-8862) 2.5-5 mg OD	0.747	± 2.741
Finerenone (BAY94-8862) 5-10 mg OD	0.887	± 2.604
Finerenone (BAY94-8862) 7.5-15 mg OD	0.809	± 2.647
Finerenone (BAY94-8862) 10-20 mg OD	0.746	± 2.472
Finerenone (BAY94-8862) 15-20 mg OD	0.849	± 2.348

Change From Baseline in KCCQ Questionnaire Scores at Specified Visits Secondary · Baseline, Day 30 and Day 90

The Kansas City Cardiomyopathy Questionnaire (KCCQ) was the leading health related quality of life measure for subjects with CHF. KCCQ was a 23 item questionnaire that independently measures the impact of subjects HF, or its treatment, on 7 distinct domains: self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Results from the total symptom summary score are present

Baseline

Group	Value	95% CI
Eplerenone (INSPRA®)	43.7	± 23
Finerenone (BAY94-8862) 2.5-5 mg OD	42.8	± 22.6
Finerenone (BAY94-8862) 5-10 mg OD	45.4	± 24
Finerenone (BAY94-8862) 7.5-15 mg OD	42.1	± 23.2
Finerenone (BAY94-8862) 10-20 mg OD	42.3	± 23.7
Finerenone (BAY94-8862) 15-20 mg OD	43.2	± 22.5

Day 30

Group	Value	95% CI
Eplerenone (INSPRA®)	20.5	± 26.2
Finerenone (BAY94-8862) 2.5-5 mg OD	18.2	± 22.7
Finerenone (BAY94-8862) 5-10 mg OD	19.3	± 26.5
Finerenone (BAY94-8862) 7.5-15 mg OD	23	± 24.4
Finerenone (BAY94-8862) 10-20 mg OD	24.9	± 22.9
Finerenone (BAY94-8862) 15-20 mg OD	20.6	± 27

Day 90

Group	Value	95% CI
Eplerenone (INSPRA®)	24.3	± 27.6
Finerenone (BAY94-8862) 2.5-5 mg OD	21.3	± 27.2
Finerenone (BAY94-8862) 5-10 mg OD	24.5	± 27
Finerenone (BAY94-8862) 7.5-15 mg OD	29.3	± 28.6
Finerenone (BAY94-8862) 10-20 mg OD	28.3	± 23.8
Finerenone (BAY94-8862) 15-20 mg OD	22.2	± 30.6

Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits Secondary · Baseline, Day 30, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L): participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher sco

Baseline

Group	Value	95% CI
Eplerenone (INSPRA®)	0.58	± 0.25
Finerenone (BAY94-8862) 2.5-5 mg OD	0.59	± 0.25
Finerenone (BAY94-8862) 5-10 mg OD	0.62	± 0.23
Finerenone (BAY94-8862) 7.5-15 mg OD	0.58	± 0.23
Finerenone (BAY94-8862) 10-20 mg OD	0.56	± 0.25
Finerenone (BAY94-8862) 15-20 mg OD	0.59	± 0.24

Day 30

Group	Value	95% CI
Eplerenone (INSPRA®)	0.06	± 0.23
Finerenone (BAY94-8862) 2.5-5 mg OD	0.02	± 0.24
Finerenone (BAY94-8862) 5-10 mg OD	0.02	± 0.23
Finerenone (BAY94-8862) 7.5-15 mg OD	0.07	± 0.22
Finerenone (BAY94-8862) 10-20 mg OD	0.06	± 0.23
Finerenone (BAY94-8862) 15-20 mg OD	0.02	± 0.25

Day 90

Group	Value	95% CI
Eplerenone (INSPRA®)	0.08	± 0.24
Finerenone (BAY94-8862) 2.5-5 mg OD	0.03	± 0.27
Finerenone (BAY94-8862) 5-10 mg OD	0.04	± 0.25
Finerenone (BAY94-8862) 7.5-15 mg OD	0.08	± 0.2
Finerenone (BAY94-8862) 10-20 mg OD	0.1	± 0.24
Finerenone (BAY94-8862) 15-20 mg OD	0.06	± 0.28

Premature discontinuation

Group	Value	95% CI
Eplerenone (INSPRA®)	-0.12	± 0.25
Finerenone (BAY94-8862) 2.5-5 mg OD	-0.06	± 0.29
Finerenone (BAY94-8862) 5-10 mg OD	-0.09	± 0.24
Finerenone (BAY94-8862) 7.5-15 mg OD	-0.1	± 0.24
Finerenone (BAY94-8862) 10-20 mg OD	-0.05	± 0.25
Finerenone (BAY94-8862) 15-20 mg OD	0	± 0.29

Follow-up

Group	Value	95% CI
Eplerenone (INSPRA®)	0.06	± 0.26
Finerenone (BAY94-8862) 2.5-5 mg OD	0.01	± 0.25
Finerenone (BAY94-8862) 5-10 mg OD	0.01	± 0.27
Finerenone (BAY94-8862) 7.5-15 mg OD	0.08	± 0.23
Finerenone (BAY94-8862) 10-20 mg OD	0.07	± 0.23
Finerenone (BAY94-8862) 15-20 mg OD	0.04	± 0.28

Change From Baseline in Serum Potassium at Specified Visits Secondary · Baseline, Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)

Baseline

Group	Value	95% CI
Eplerenone (INSPRA®)	4.159	± 0.495
Finerenone (BAY94-8862) 2.5-5 mg OD	4.081	± 0.501
Finerenone (BAY94-8862) 5-10 mg OD	4.211	± 0.541
Finerenone (BAY94-8862) 7.5-15 mg OD	4.174	± 0.443
Finerenone (BAY94-8862) 10-20 mg OD	4.131	± 0.506
Finerenone (BAY94-8862) 15-20 mg OD	4.117	± 0.506

Day 30

Group	Value	95% CI
Eplerenone (INSPRA®)	0.057	± 0.608
Finerenone (BAY94-8862) 2.5-5 mg OD	0.135	± 0.573
Finerenone (BAY94-8862) 5-10 mg OD	0.075	± 0.523
Finerenone (BAY94-8862) 7.5-15 mg OD	0.085	± 0.475
Finerenone (BAY94-8862) 10-20 mg OD	0.21	± 0.592
Finerenone (BAY94-8862) 15-20 mg OD	0.193	± 0.556

Day 60

Group	Value	95% CI
Eplerenone (INSPRA®)	0.179	± 0.589
Finerenone (BAY94-8862) 2.5-5 mg OD	0.091	± 0.568
Finerenone (BAY94-8862) 5-10 mg OD	0.131	± 0.566
Finerenone (BAY94-8862) 7.5-15 mg OD	0.171	± 0.54
Finerenone (BAY94-8862) 10-20 mg OD	0.274	± 0.522
Finerenone (BAY94-8862) 15-20 mg OD	0.216	± 0.547

Day 90

Group	Value	95% CI
Eplerenone (INSPRA®)	0.307	± 0.609
Finerenone (BAY94-8862) 2.5-5 mg OD	0.184	± 0.574
Finerenone (BAY94-8862) 5-10 mg OD	0.153	± 0.516
Finerenone (BAY94-8862) 7.5-15 mg OD	0.164	± 0.579
Finerenone (BAY94-8862) 10-20 mg OD	0.275	± 0.58
Finerenone (BAY94-8862) 15-20 mg OD	0.245	± 0.574

Follow-up

Group	Value	95% CI
Eplerenone (INSPRA®)	0.117	± 0.621
Finerenone (BAY94-8862) 2.5-5 mg OD	0.226	± 0.694
Finerenone (BAY94-8862) 5-10 mg OD	0.054	± 0.623
Finerenone (BAY94-8862) 7.5-15 mg OD	0.05	± 0.572
Finerenone (BAY94-8862) 10-20 mg OD	0.175	± 0.559
Finerenone (BAY94-8862) 15-20 mg OD	0.036	± 0.556

Change From Baseline in Systolic Blood Pressure at Specified Visits Secondary · Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

Baseline

Group	Value	95% CI
Eplerenone (INSPRA®)	120.554	± 18.706
Finerenone (BAY94-8862) 2.5-5 mg OD	119.492	± 16.348
Finerenone (BAY94-8862) 5-10 mg OD	118.498	± 14.355
Finerenone (BAY94-8862) 7.5-15 mg OD	119.087	± 16.677
Finerenone (BAY94-8862) 10-20 mg OD	116.024	± 16.895
Finerenone (BAY94-8862) 15-20 mg OD	116.941	± 16.548

Day 7

Group	Value	95% CI
Eplerenone (INSPRA®)	-0.541	± 13.894
Finerenone (BAY94-8862) 2.5-5 mg OD	-3.178	± 13.72
Finerenone (BAY94-8862) 5-10 mg OD	-2.565	± 12.278
Finerenone (BAY94-8862) 7.5-15 mg OD	0.568	± 12.733
Finerenone (BAY94-8862) 10-20 mg OD	0.162	± 15.416
Finerenone (BAY94-8862) 15-20 mg OD	-0.546	± 13.498

Day 14

Group	Value	95% CI
Eplerenone (INSPRA®)	-3.442	± 14.258
Finerenone (BAY94-8862) 2.5-5 mg OD	-4.488	± 10.31
Finerenone (BAY94-8862) 5-10 mg OD	4.142	± 15.001
Finerenone (BAY94-8862) 7.5-15 mg OD	1.241	± 13.561
Finerenone (BAY94-8862) 10-20 mg OD	-3.099	± 12.591
Finerenone (BAY94-8862) 15-20 mg OD	-2.906	± 15.406

Day 30

Group	Value	95% CI
Eplerenone (INSPRA®)	0.067	± 15.312
Finerenone (BAY94-8862) 2.5-5 mg OD	-0.824	± 15.747
Finerenone (BAY94-8862) 5-10 mg OD	-0.367	± 14.984
Finerenone (BAY94-8862) 7.5-15 mg OD	0.374	± 14.433
Finerenone (BAY94-8862) 10-20 mg OD	1.786	± 15.039
Finerenone (BAY94-8862) 15-20 mg OD	0.899	± 14.608

Day 60

Group	Value	95% CI
Eplerenone (INSPRA®)	0.684	± 16.315
Finerenone (BAY94-8862) 2.5-5 mg OD	0.337	± 14.176
Finerenone (BAY94-8862) 5-10 mg OD	-1.249	± 13.659
Finerenone (BAY94-8862) 7.5-15 mg OD	-1.811	± 14.462
Finerenone (BAY94-8862) 10-20 mg OD	0.981	± 15.525
Finerenone (BAY94-8862) 15-20 mg OD	0.667	± 14.83

Day 90

Group	Value	95% CI
Eplerenone (INSPRA®)	-0.967	± 16.408
Finerenone (BAY94-8862) 2.5-5 mg OD	0.922	± 15.847
Finerenone (BAY94-8862) 5-10 mg OD	0.047	± 15.643
Finerenone (BAY94-8862) 7.5-15 mg OD	-0.664	± 15.018
Finerenone (BAY94-8862) 10-20 mg OD	1.216	± 17.831
Finerenone (BAY94-8862) 15-20 mg OD	0.956	± 15.743

Premature discontinuation

Group	Value	95% CI
Eplerenone (INSPRA®)	-2.991	± 16.456
Finerenone (BAY94-8862) 2.5-5 mg OD	-0.41	± 13.936
Finerenone (BAY94-8862) 5-10 mg OD	-2.167	± 19.963
Finerenone (BAY94-8862) 7.5-15 mg OD	9.391	± 22.378
Finerenone (BAY94-8862) 10-20 mg OD	-2.32	± 11.963
Finerenone (BAY94-8862) 15-20 mg OD	-0.028	± 15.42

Follow-up

Group	Value	95% CI
Eplerenone (INSPRA®)	0.188	± 16.751
Finerenone (BAY94-8862) 2.5-5 mg OD	2.869	± 15.502
Finerenone (BAY94-8862) 5-10 mg OD	1.95	± 16.148
Finerenone (BAY94-8862) 7.5-15 mg OD	-0.928	± 17.953
Finerenone (BAY94-8862) 10-20 mg OD	2.041	± 16.189
Finerenone (BAY94-8862) 15-20 mg OD	3.037	± 16.782

Change From Baseline in Diastolic Blood Pressure at Specified Visits Secondary · Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

Baseline

Group	Value	95% CI
Eplerenone (INSPRA®)	71.633	± 11.647
Finerenone (BAY94-8862) 2.5-5 mg OD	71.044	± 10.762
Finerenone (BAY94-8862) 5-10 mg OD	71.442	± 8.508
Finerenone (BAY94-8862) 7.5-15 mg OD	70.61	± 9.692
Finerenone (BAY94-8862) 10-20 mg OD	70.343	± 10.394
Finerenone (BAY94-8862) 15-20 mg OD	71.145	± 9.809

Day 7

Group	Value	95% CI
Eplerenone (INSPRA®)	-1.351	± 10.237
Finerenone (BAY94-8862) 2.5-5 mg OD	-1.693	± 9.911
Finerenone (BAY94-8862) 5-10 mg OD	-2.143	± 9.848
Finerenone (BAY94-8862) 7.5-15 mg OD	0.013	± 9.733
Finerenone (BAY94-8862) 10-20 mg OD	-0.738	± 10.534
Finerenone (BAY94-8862) 15-20 mg OD	-1.166	± 8.964

Day 14

Group	Value	95% CI
Eplerenone (INSPRA®)	-3.442	± 10.089
Finerenone (BAY94-8862) 2.5-5 mg OD	-0.537	± 9.59
Finerenone (BAY94-8862) 5-10 mg OD	1.608	± 9.423
Finerenone (BAY94-8862) 7.5-15 mg OD	-0.083	± 7.421
Finerenone (BAY94-8862) 10-20 mg OD	-2.387	± 10.51
Finerenone (BAY94-8862) 15-20 mg OD	-0.625	± 9.41

Day 30

Group	Value	95% CI
Eplerenone (INSPRA®)	-0.503	± 10.826
Finerenone (BAY94-8862) 2.5-5 mg OD	0.146	± 10.667
Finerenone (BAY94-8862) 5-10 mg OD	-0.845	± 8.91
Finerenone (BAY94-8862) 7.5-15 mg OD	-0.068	± 9.633
Finerenone (BAY94-8862) 10-20 mg OD	-0.094	± 10.086
Finerenone (BAY94-8862) 15-20 mg OD	-1.163	± 9.622

Day 60

Group	Value	95% CI
Eplerenone (INSPRA®)	-0.613	± 11.096
Finerenone (BAY94-8862) 2.5-5 mg OD	-0.199	± 11.297
Finerenone (BAY94-8862) 5-10 mg OD	-2.144	± 9.552
Finerenone (BAY94-8862) 7.5-15 mg OD	-0.85	± 10.472
Finerenone (BAY94-8862) 10-20 mg OD	0.17	± 10.312
Finerenone (BAY94-8862) 15-20 mg OD	-0.575	± 10.427

Day 90

Group	Value	95% CI
Eplerenone (INSPRA®)	-0.716	± 11.035
Finerenone (BAY94-8862) 2.5-5 mg OD	-0.106	± 11.148
Finerenone (BAY94-8862) 5-10 mg OD	-1.738	± 9.015
Finerenone (BAY94-8862) 7.5-15 mg OD	-1.121	± 9.96
Finerenone (BAY94-8862) 10-20 mg OD	-0.545	± 11.212
Finerenone (BAY94-8862) 15-20 mg OD	-0.877	± 11.327

Premature discontinuation

Group	Value	95% CI
Eplerenone (INSPRA®)	-3.185	± 11.853
Finerenone (BAY94-8862) 2.5-5 mg OD	0.868	± 9.239
Finerenone (BAY94-8862) 5-10 mg OD	-2.194	± 15.522
Finerenone (BAY94-8862) 7.5-15 mg OD	4.101	± 12.151
Finerenone (BAY94-8862) 10-20 mg OD	-2.96	± 9.199
Finerenone (BAY94-8862) 15-20 mg OD	-0.083	± 10.113

Follow-up

Group	Value	95% CI
Eplerenone (INSPRA®)	-1.218	± 11.477
Finerenone (BAY94-8862) 2.5-5 mg OD	0.696	± 13.172
Finerenone (BAY94-8862) 5-10 mg OD	-0.444	± 10.197
Finerenone (BAY94-8862) 7.5-15 mg OD	-1.16	± 11.114
Finerenone (BAY94-8862) 10-20 mg OD	-0.298	± 11.521
Finerenone (BAY94-8862) 15-20 mg OD	-0.172	± 10.211

Change From Baseline in Heart Rate at Specified Visits Secondary · Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

Baseline

Group	Value	95% CI
Eplerenone (INSPRA®)	74.957	± 13.813
Finerenone (BAY94-8862) 2.5-5 mg OD	73.369	± 13.396
Finerenone (BAY94-8862) 5-10 mg OD	72.681	± 12.623
Finerenone (BAY94-8862) 7.5-15 mg OD	74.184	± 12.369
Finerenone (BAY94-8862) 10-20 mg OD	73.852	± 11.999
Finerenone (BAY94-8862) 15-20 mg OD	74.329	± 13.187

Day 7

Group	Value	95% CI
Eplerenone (INSPRA®)	-0.8	± 10.751
Finerenone (BAY94-8862) 2.5-5 mg OD	1.073	± 13.5
Finerenone (BAY94-8862) 5-10 mg OD	-0.63	± 11.696
Finerenone (BAY94-8862) 7.5-15 mg OD	-0.719	± 10.77
Finerenone (BAY94-8862) 10-20 mg OD	-0.548	± 11.144
Finerenone (BAY94-8862) 15-20 mg OD	-1.176	± 13.398

Day 14

Group	Value	95% CI
Eplerenone (INSPRA®)	-3.109	± 15.101
Finerenone (BAY94-8862) 2.5-5 mg OD	0.599	± 16.387
Finerenone (BAY94-8862) 5-10 mg OD	1.842	± 14.988
Finerenone (BAY94-8862) 7.5-15 mg OD	-1.324	± 13.666
Finerenone (BAY94-8862) 10-20 mg OD	0.423	± 11.247
Finerenone (BAY94-8862) 15-20 mg OD	-3.969	± 13.715

Day 30

Group	Value	95% CI
Eplerenone (INSPRA®)	0.294	± 13.61
Finerenone (BAY94-8862) 2.5-5 mg OD	1.064	± 14.128
Finerenone (BAY94-8862) 5-10 mg OD	0.435	± 13.63
Finerenone (BAY94-8862) 7.5-15 mg OD	-0.349	± 12.636
Finerenone (BAY94-8862) 10-20 mg OD	-0.802	± 11.311
Finerenone (BAY94-8862) 15-20 mg OD	-1.633	± 12.719

Day 60

Group	Value	95% CI
Eplerenone (INSPRA®)	0.297	± 13.033
Finerenone (BAY94-8862) 2.5-5 mg OD	-0.975	± 14.953
Finerenone (BAY94-8862) 5-10 mg OD	-1.741	± 10.86
Finerenone (BAY94-8862) 7.5-15 mg OD	-2.318	± 14.225
Finerenone (BAY94-8862) 10-20 mg OD	0.192	± 13.377
Finerenone (BAY94-8862) 15-20 mg OD	-1.608	± 13.828

Day 90

Group	Value	95% CI
Eplerenone (INSPRA®)	-0.189	± 12.289
Finerenone (BAY94-8862) 2.5-5 mg OD	-1.647	± 13.001
Finerenone (BAY94-8862) 5-10 mg OD	-2.89	± 12.034
Finerenone (BAY94-8862) 7.5-15 mg OD	-2.212	± 12.041
Finerenone (BAY94-8862) 10-20 mg OD	-0.71	± 13.777
Finerenone (BAY94-8862) 15-20 mg OD	-1.145	± 14.284

Premature discontinuation

Group	Value	95% CI
Eplerenone (INSPRA®)	-2.278	± 15.909
Finerenone (BAY94-8862) 2.5-5 mg OD	-1.424	± 15.587
Finerenone (BAY94-8862) 5-10 mg OD	-0.222	± 7.591
Finerenone (BAY94-8862) 7.5-15 mg OD	1.101	± 10.22
Finerenone (BAY94-8862) 10-20 mg OD	4.733	± 13.646
Finerenone (BAY94-8862) 15-20 mg OD	-2.072	± 19.731

Follow-up

Group	Value	95% CI
Eplerenone (INSPRA®)	-1.281	± 13.789
Finerenone (BAY94-8862) 2.5-5 mg OD	-2.057	± 13.982
Finerenone (BAY94-8862) 5-10 mg OD	-0.626	± 14.196
Finerenone (BAY94-8862) 7.5-15 mg OD	-1.326	± 15.488
Finerenone (BAY94-8862) 10-20 mg OD	0.834	± 14.159
Finerenone (BAY94-8862) 15-20 mg OD	-1.317	± 14.636

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events: from the start of study treatment until 3 days post-last dose, up to approximately 93 days. All Cause Mortality: assessed until 30 days post-last dose, up to approximately 120 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Eplerenone (INSPRA®)

Serious: 77/221 (35%)

Deaths: 19/221

Finerenone(BAY94-8862) 2.5-5 mg OD

Serious: 72/172 (42%)

Deaths: 17/172

Finerenone (BAY94-8862) 5-10 mg OD

Serious: 47/163 (29%)

Deaths: 9/163

Finerenone (BAY94-8862) 7.5-15 mg OD

Serious: 52/167 (31%)

Deaths: 12/167

Finerenone (BAY94-8862) 10-20 mg OD

Serious: 46/169 (27%)

Deaths: 2/169

Finerenone (BAY94-8862) 15-20 mg OD

Serious: 57/163 (35%)

Deaths: 9/163

Serious adverse events (172 terms)

Reaction	System	Eplerenone (INSPRA®)	Finerenone(BAY94-8862) 2.5…	Finerenone (BAY94-8862) 5-…	Finerenone (BAY94-8862) 7.…	Finerenone (BAY94-8862) 10…	Finerenone (BAY94-8862) 15…
Cardiac failure	Cardiac disorders	—	—	—	—	—	—
Cardiac failure chronic	Cardiac disorders	—	—	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Cardiac failure acute	Cardiac disorders	—	—	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—	—	—
Renal failure acute	Renal and urinary disorders	—	—	—	—	—	—
Ventricular tachycardia	Cardiac disorders	—	—	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—	—	—
Ventricular fibrillation	Cardiac disorders	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—
Renal failure chronic	Renal and urinary disorders	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—	—	—
Sudden death	General disorders	—	—	—	—	—	—
Sudden cardiac death	General disorders	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—
Erysipelas	Infections and infestations	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—
Septic shock	Infections and infestations	—	—	—	—	—	—
Blood potassium increased	Investigations	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—	—
Ischaemic stroke	Nervous system disorders	—	—	—	—	—	—
Renal failure	Renal and urinary disorders	—	—	—	—	—	—

Other adverse events (10 terms — click to expand)

Reaction	System	Eplerenone (INSPRA®)	Finerenone(BAY94-8862) 2.5…	Finerenone (BAY94-8862) 5-…	Finerenone (BAY94-8862) 7.…	Finerenone (BAY94-8862) 10…	Finerenone (BAY94-8862) 15…
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Renal impairment	Renal and urinary disorders	—	—	—	—	—	—

Most-reported serious reactions: Cardiac failure, Cardiac failure chronic, Hyperkalaemia, Cardiac failure acute, Cardiac failure congestive, Renal failure acute, Ventricular tachycardia, Cardiac arrest.

Data from ClinicalTrials.gov NCT01807221 adverse events section.

Sponsor's own description

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Safety and tolerability of the novel non-steroidal mineralocorticoid receptor antagonist BAY 94-8862 in patients with chronic heart failure and mild or moderate chronic kidney disease: a randomized, double-blind trial.
Pitt B, Kober L, Ponikowski P, Gheorghiade M, et al · · 2013 · cited 438× · PMID 23713082 · DOI 10.1093/eurheartj/eht187
A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease.
Filippatos G, Anker SD, Böhm M, Gheorghiade M, et al · · 2016 · cited 302× · PMID 27130705 · DOI 10.1093/eurheartj/ehw132
The New Biology of Diabetic Kidney Disease-Mechanisms and Therapeutic Implications.
Lytvyn Y, Bjornstad P, van Raalte DH, Heerspink HL, et al · · 2020 · cited 108× · PMID 31633153 · DOI 10.1210/endrev/bnz010
Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease.
Chung EY, Ruospo M, Natale P, Bolignano D, et al · · 2020 · cited 84× · PMID 33107592 · DOI 10.1002/14651858.cd007004.pub4
Improving the residual risk of renal and cardiovascular outcomes in diabetic kidney disease: A review of pathophysiology, mechanisms, and evidence from recent trials.
Chaudhuri A, Ghanim H, Arora P. · · 2022 · cited 71× · PMID 34779091 · DOI 10.1111/dom.14601
Rationale and design of MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF): a randomized study of finerenone vs. eplerenone in patients who have worsening chronic heart failure with diabetes and/or chronic kidney disease.
Pitt B, Anker SD, Böhm M, Gheorghiade M, et al · · 2015 · cited 66× · PMID 25678098 · DOI 10.1002/ejhf.218
Third-generation Mineralocorticoid Receptor Antagonists: Why Do We Need a Fourth?
Gomez-Sanchez EP. · · 2016 · cited 36× · PMID 26466326 · DOI 10.1097/fjc.0000000000000329
Cardiovascular-renal protective effect and molecular mechanism of finerenone in type 2 diabetic mellitus.
Lv R, Xu L, Che L, Liu S, et al · · 2023 · cited 30× · PMID 36860374 · DOI 10.3389/fendo.2023.1125693

Verify or expand the search:

Other trials of Finerenone (BAY94-8862)

Trials testing the same drug.

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NCT02540993 — Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease · Phase 3 · completed

Other recruiting trials for Heart Failure

Currently open trials in the same condition.

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Other Bayer trials

Trials by the same sponsor.

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NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01807221 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 6 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01807221.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01807221: ARTS-HF

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (172 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Finerenone (BAY94-8862)

Other recruiting trials for Heart Failure

Other Bayer trials

Verify against primary sources