Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction

Sponsor
Morten Schou
Study ID
NCT03198585
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    Capsule, once a day for 90 days
  • Placebo — OTHER
    Capsule, once a day for 90 days

Study Details

To assess the effect of Empagliflozin on cardiac biomarkers, cardiac function at rest and during stress, cardiac hemodynamics, renal function, metabolism, daily activity level and health-related quality of life in stable, symptomatic heart failure patients with reduced left ventricular ejection fraction. The primary hypothesis is that 3 months' treatment with Empagliflozin 10 mg a day will reduce the plasma concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP).

Key Dates

Start date
Jun 29, 2017
Status verified
Jan 2020
Primary completion
Dec 20, 2019
Completion
Jan 17, 2020

Study Design

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

Arms

  • Active Comparator: Empagliflozin 10 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Between-group difference in the change of plasma concentrations of NT-proBNP [ Time Frame: 90 days ]

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