18 and older, any sex, with Cardiovascular Diseases. 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.
Change in Left Ventricle-end Systolic Volume (ESV)Primary· Baseline and 6 months
End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction of the left ventricle (LV). Change from baseline to study end at 6 months.
Group
Value
95% CI
Empagliflozin
-26.6
± 20.5
Placebos
-0.5
± 21.9
Change in LV-end Diastolic Volume (EDV)Primary· Baseline and 6 months
End-diastolic volume (EDV) is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole. Change from baseline to study end at 6 months.
Group
Value
95% CI
Empagliflozin
-25.1
± 26
Placebos
-1.5
± 25.4
Change in LV-Ejection Fraction IndexSecondary· Baseline and 6 months
The volumetric fraction of blood ejected from the left ventricle of the heart with each heartbeat. Change from baseline to study end at 6 months.
Group
Value
95% CI
Empagliflozin
6.0
± 4.2
Placebos
-0.1
± 3.9
Change in VO2 ConsumptionSecondary· Baseline and 6 months
Oxygen consumption - the amount of oxygen consumed by the tissues of the body, usually measured as the oxygen uptake in the lung, also called the V02max measure. Change from baseline to study end at 6 months.
Group
Value
95% CI
Empagliflozin
1.1
± 2.6
Placebos
-0.5
± 1.9
Change in 6 Min Walk TestSecondary· Baseline and 6 months
The distance covered over a time of 6 minutes. Change from baseline to study end at 6 months.
Group
Value
95% CI
Empagliflozin
81
± 64
Placebos
-35
± 68
Change in Kansas Cardiomyopathy Questionnaire (KCCQ-12)Secondary· Baseline and 6 months
The KCCQ-12 is an instrument most widely used to evaluate QoL in Heart Failure (HF) patients. It is a questionnaire containing 12 questions with full scores ranging from 12 (poor quality of life) to 70 (good quality of life). Higher score indicates better quality of life. Change from baseline to study end at 6 months.
Group
Value
95% CI
Empagliflozin
21
± 18
Placebos
1.9
± 15
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Purpose:
The overall hypothesis of the study is that the benefits attained in the EMPA-OUTCOME were, at least in part, mediated by a glucose-independent mechanism. Thus, to demonstrate the existence of the postulated non-glucose dependent effects, the researchers will investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in heart failure patients with reduced ejection fraction without diabetes.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07060417 — Vascular Effects of SGLT2i in Non-diabetic CKD
· Phase 2
· not yet recruiting
NCT06625073 — Randomized Trial of SGLT2i in Heart Transplant Recipients
· Phase 4
· recruiting
NCT07107945 — A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease
· Phase 3
· recruiting
NCT07214818 — SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome
· Phase 2, PHASE3
· active not recruiting
NCT07180745 — Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease
· Phase 4
· not yet recruiting
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Currently open trials in the same condition.
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Other Icahn School of Medicine at Mount Sinai trials
Trials by the same sponsor.
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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 Icahn School of Medicine at Mount Sinai
Last refreshed: 25 March 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/NCT03485222.