NCT03730961 is a Phase 2 clinical trial of BMS-986231 in Cardiac Failure, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT03730961?

NCT03730961 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT03730961?

Interventions in NCT03730961: BMS-986231, Furosemide, Placebo.

What condition does NCT03730961 study?

NCT03730961 studies Cardiac Failure, Myocardial Failure, Congestive Heart Failure, Heart Decompensation.

Is NCT03730961 still recruiting?

NCT03730961 is currently completed. Last updated 26 February 2021.

Are results published for NCT03730961?

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

Last reviewed 2021-02-26 · How we verify

NCT03730961

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

An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic

Completed Phase 2 Results posted Last updated 26 February 2021

What this trial tests

Phase 2 trial testing BMS-986231 in Cardiac Failure in 23 participants. Completed in 9 January 2020.

Timeline

17 January 2019

Primary endpoint
11 December 2019

9 January 2020

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	23
Start date	17 January 2019
Primary completion	11 December 2019
Estimated completion	9 January 2020
Sites	2 locations across United Kingdom

Drugs / interventions tested

BMS-986231 — full drug profile →
Furosemide (furosemide) — full drug profile →
Placebo

Conditions studied

Cardiac Failure — all drugs for Cardiac Failure →
Myocardial Failure — all drugs for Myocardial Failure →
Congestive Heart Failure — all drugs for Congestive Heart Failure →
Heart Decompensation — all drugs for Heart Decompensation →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Cardiac Failure or Myocardial 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.

4-hour Urinary Output Following Intravenous Administration of 40 mg Furosemide to HFrEF Participants Receiving BMS-986231 Infusion Compared to Placebo Primary · 4 hours

The total volume of urinary output 4 hours after 40 mg furosemide bolus given to participants with HFrEF while on BMS-986231 compared to placebo: absolute difference in total volume and % change from placebo. Sequence 1: Placebo in period 1, drug in period 2 Sequence 2: Drug in period 1, placebo in period 2

Sequence 1

Group	Value	95% CI
BMS-986231	900.7	± 366.56
Placebo	1603.3	± 674.18

Sequence 2

Group	Value	95% CI
BMS-986231	1176.7	± 386.21
Placebo	1345.4	± 391.11

Total

Group	Value	95% CI
BMS-986231	1032.1	± 392.74
Placebo	1480.5	± 559.92

FeNa in Participants With HFrEF While on BMS-986231 Compared to Placebo Secondary · Day 1, predose; 0-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours

Secondary efficacy analyses was performed using the randomized population. The FeNa, FeK, furosemide urinary and plasma concentration and the ratio of urinary sodium to urinary furosemide was calculated at each time point over 4-hour urine/plasma collection after a bolus injection of 40 mg furosemide while receiving BMS-986231 or placebo. Fractional Excretion Na = ((Urine Sodium \* Plasma Creatinine) / (Plasma Sodium \* Urine Creatinine)) \* 100

Before start of infusion

Group	Value	95% CI
BMS-986231	0.5	± 0.52
Placebo	0.6	± 0.73

0-4 hours

Group	Value	95% CI
BMS-986231	0.6	± 0.67
Placebo	0.7	± 0.84

4-5 hours

Group	Value	95% CI
BMS-986231	4.6	± 3.34
Placebo	5.4	± 3.09

5-6 hours

Group	Value	95% CI
BMS-986231	5.0	± 2.87
Placebo	7.0	± 3.51

6-7 hours

Group	Value	95% CI
BMS-986231	3.3	± 2.33
Placebo	4.7	± 2.79

7-8 hours

Group	Value	95% CI
BMS-986231	1.7	± 1.26
Placebo	3.3	± 2.52

FeK in Participants With HFrEF While on BMS-986231 Compared to Placebo Secondary · Day 1, predose; 0-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours

Secondary efficacy analyses was performed using the randomized population. The FeNa, FeK, furosemide urinary and plasma concentration and the ratio of urinary sodium to urinary furosemide was calculated at each time point over 4-hour urine/plasma collection after a bolus injection of 40 mg furosemide while receiving BMS-986231 or placebo. Fractional Excretion K = ((Urine Potassium \* Plasma Creatinine) / (Plasma Potassium \* Urine Creatinine)) \* 100

Before start of infusion

Group	Value	95% CI
BMS-986231	0.4	± 0.16
Placebo	0.4	± 0.17

0-4 hours

Group	Value	95% CI
BMS-986231	0.5	± 0.20
Placebo	0.4	± 0.17

4-5 hours

Group	Value	95% CI
BMS-986231	1.1	± 0.67
Placebo	0.9	± 0.46

5-6 hours

Group	Value	95% CI
BMS-986231	1.2	± 0.54
Placebo	1.2	± 0.52

6-7 hours

Group	Value	95% CI
BMS-986231	1.1	± 0.42
Placebo	1.0	± 0.35

7-8 hours

Group	Value	95% CI
BMS-986231	1.0	± 0.32
Placebo	0.8	± 0.32

Furosemide Urinary Concentrations Secondary · Day 1, predose, 0-2 hours, 2-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours, 8-10 hours

Summary of urine recovery by interval, measured by amount excreted.

Before start of infusion

Group	Value	95% CI
BMS-986231	0.2	± 0.13
Placebo	0.2	± 0.11

0-2 hours

Group	Value	95% CI
BMS-986231	0.1	± 0.08
Placebo	0.1	± 0.11

2-4 hours

Group	Value	95% CI
BMS-986231	0.3	± 0.37
Placebo	0.1	± 0.11

4-5 hours

Group	Value	95% CI
BMS-986231	7.9	± 4.66
Placebo	8.2	± 4.56

5-6 hours

Group	Value	95% CI
BMS-986231	4.3	± 1.74
Placebo	3.7	± 1.48

6-7 hours

Group	Value	95% CI
BMS-986231	2.8	± 2.03
Placebo	2.7	± 1.43

7-8 hours

Group	Value	95% CI
BMS-986231	2.0	± 1.22
Placebo	1.7	± 1.15

8-10 hours

Group	Value	95% CI
BMS-986231	1.7	± 1.28
Placebo	1.6	± 1.00

Furosemide Plasma Concentrations Secondary · Day 1: 4, 5, 6, 8, 10 hours

Summary of plasma concentrations by interval.

4 hours post-dose

Group	Value	95% CI
BMS-986231	1605	± 5384
Placebo	63.6	± 140.3

5 hours post-dose

Group	Value	95% CI
BMS-986231	2049	± 593.0
Placebo	2145	± 653.2

6 hours post-dose

Group	Value	95% CI
BMS-986231	1122	± 437.6
Placebo	1146	± 466.8

8 hours post-dose

Group	Value	95% CI
BMS-986231	426.8	± 204.8
Placebo	476.6	± 226.0

10 hours post-dose

Group	Value	95% CI
BMS-986231	345.6	± 386.6
Placebo	244.3	± 164.3

Ratio Urinary Sodium (Na) to Urinary Furosemide at 8 Hours Post-start Infusion Secondary · 0-4 hours after furosemide

Summary of urinary concentrations 0-4 hours after furosemide Ratio = Cumulative Sodium Excretion / Cumulative Furosemide in Urine

Group	Value	95% CI
BMS-986231	6.1	± 3.18
Placebo	10.1	± 4.74

Number of Participants With Clinically Relevant Hypotension Secondary · up to 8 hours

Clinically relevant hypotension is defined as systolic blood pressure (SBP) \< 90 mmHg or symptomatic hypotension during infusion

Group	Value	95% CI
BMS-986231	4
Placebo	0

Number of Participants With an Adverse Event (AE) Secondary · up to 8 days

Clinically relevant hypotension is defined as systolic blood pressure (SBP) \< 90 mmHg or symptomatic hypotension during infusion

Group	Value	95% CI
BMS-986231	8
Placebo	6

Number of Participants With an Abnormal Clinical Laboratory Value Secondary · from first dose to 30 days post-last dose (ca. 5-8 weeks)

Number of participants who experienced an in-study abnormal clinical laboratory event under the category of Hematology, Chemistry or Urinalysis.

Group	Value	95% CI
BMS-986231	0
Placebo	0

Change From Baseline in Vital Signs - Blood Pressure Secondary · Day 1, 8 hours post-dose (end of infusion)

The change in baseline for vital signs was reported for each arm.

diastolic blood pressure

Group	Value	95% CI
BMS-986231	-14.5	± 9.99
Placebo	-0.6	± 10.46

systolic blood pressure

Group	Value	95% CI
BMS-986231	-28.4	± 15.60
Placebo	-4.9	± 14.55

Change From Baseline in Vital Signs - Heart Rate Secondary · Day 1, 8 hours post-dose (end of infusion)

The change in baseline for vital signs was reported for each arm.

Group	Value	95% CI
BMS-986231	0.5	± 10.40
Placebo	-0.1	± 8.08

Change From Baseline in Vital Signs - Oxygen Saturation Secondary · Day 1, 8 hours post-dose (end of infusion)

The change in baseline for vital signs was reported for each arm.

Group	Value	95% CI
BMS-986231	-1.0	± 1.82
Placebo	0.0	± 1.56

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose to 100 days post-last dose (up to ca. 4 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BMS-986231

Serious: 1/23 (4%)

Deaths: 0/23

Placebo

Serious: 2/23 (9%)

Deaths: 0/23

Serious adverse events (5 terms)

Reaction	System	BMS-986231	Placebo
Myocardial infarction	Cardiac disorders	—	—
Lower respiratory tract infection	Infections and infestations	—	—
Acute kidney injury	Renal and urinary disorders	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	BMS-986231	Placebo
Headache	Nervous system disorders	—	—
Hypotension	Vascular disorders	—	—
Lower respiratory tract infection	Infections and infestations	—	—
Dizziness	Nervous system disorders	—	—

Most-reported serious reactions: Myocardial infarction, Lower respiratory tract infection, Acute kidney injury, Chronic obstructive pulmonary disease, Dyspnoea.

Data from ClinicalTrials.gov NCT03730961 adverse events section.

Sponsor's own description

The purpose of this study is to investigate continuous 8-hour introductions of BMS-986231 in participants with heart failure and weakened heart function given a standard dose of diuretic.

Publications & conference data

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

Leveraging Signaling Pathways to Treat Heart Failure With Reduced Ejection Fraction.
Pinilla-Vera M, Hahn VS, Kass DA. · · 2019 · cited 38× · PMID 31120818 · DOI 10.1161/circresaha.119.313682
The interplay of inflammation, exosomes and Ca<sup>2+</sup> dynamics in diabetic cardiomyopathy.
Sanganalmath SK, Dubey S, Veeranki S, Narisetty K, et al · · 2023 · cited 29× · PMID 36804872 · DOI 10.1186/s12933-023-01755-1
Targeting Ca<sup>2 +</sup> Handling Proteins for the Treatment of Heart Failure and Arrhythmias.
Njegic A, Wilson C, Cartwright EJ. · · 2020 · cited 24× · PMID 33013458 · DOI 10.3389/fphys.2020.01068
Targeting Calcium Regulation for Heart Failure and Arrhythmia Therapeutics: A Critical Review.
Redel-Traub G, Marx SO, Marks AR. · · 2025 · cited 1× · PMID 41021670 · DOI 10.1161/circulationaha.125.075150

Verify or expand the search:

Other trials of BMS-986231

Trials testing the same drug.

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NCT03210909 — Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants · Phase 1 · completed
NCT02932969 — Study With Healthy Japanese and Non-Asian Participants With BMS-986231 · Phase 1 · completed

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Other Bristol-Myers Squibb trials

Trials by the same sponsor.

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NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · 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 NCT03730961 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Bristol-Myers Squibb
Last refreshed: 26 February 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/NCT03730961.

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

NCT03730961

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 (5 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of BMS-986231

Other recruiting trials for Cardiac Failure

Other Bristol-Myers Squibb trials

Verify against primary sources