Are the "Cardiac Benefits" of Empagliflozin Independent of Its Hypoglycemic Activity? (ATRU-4).

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT03485222
Phase
PHASE4
Status
Completed

Conditions

  • Cardiovascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    6 months
  • Placebos — DRUG
    placebo equivalent for 6 months

Study Details

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.

Key Dates

Start date
May 21, 2018
Status verified
Mar 2021
Primary completion
Feb 13, 2020
Completion
Feb 13, 2020

Study Design

Enrollment
84 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin
    10mg once a day
  • Placebo Comparator: Placebos
    placebo once a day

Primary Outcome Measure

Change in Left Ventricle-end Systolic Volume (ESV) [ Time Frame: Baseline and 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai Heart - Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

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Mount Sinai Heart - Icahn School of Medicine at Mount Sinai· New York, NY

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