This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms

Conditions

• Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Empagliflozin — DRUG
  Film-coated tablet
• Placebo — DRUG
  Film-coated tablet

Study Details

The primary objective of the study is to evaluate the effect of empagliflozin 10 mg versus placebo on exercise ability using the 6 minute walk test in patients with chronic HF with reduced ejection fraction (LVEF ≤ 40%) Secondary objectives are to assess Patient-Reported Outcome (PRO)

Key Dates

Start date

Mar 20, 2018

Status verified

Nov 2020

Primary completion

Sep 30, 2019

Completion

Oct 7, 2019

Study Design

Enrollment

312 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Empagliflozin
• Placebo Comparator: Placebo

Primary Outcome Measure

Change From Baseline to Week 12 in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance [ Time Frame: At baseline and at week 12 ]

Locations (41)

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