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

NCT03448406 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2020-12-08

Study results available
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Summary

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 (6MWT) in patients with chronic heart failure (CHF) with preserved ejection fraction (LVEF \> 40%).

Secondary objectives are to assess Patient-Reported Outcome (PRO)

Conditions

Interventions

DRUG

Empagliflozin

Film-coated tablet

DRUG

Placebo

Film-coated tablet

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2019-10-04
Completion
2019-10-09
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Greece
  • Italy
  • Norway
  • Poland
  • Portugal
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03448406 on ClinicalTrials.gov