A Study That Looks at the Function of the Heart in Patients With Heart Failure Who Take Empagliflozin

Sponsor
Boehringer Ingelheim
Study ID
NCT03332212
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The objective of this trial is to assess the effect of empagliflozin on cardiac physiology and metabolism aiming to provide a scientific explanation of the underlying mechanism by which empagliflozin improves HF related outcomes in patients with chronic heart failure

Key Dates

Start date
Mar 1, 2018
Status verified
May 2021
Primary completion
May 21, 2020
Completion
May 28, 2020

Study Design

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

Arms

  • Experimental: Cohort A (Empagliflozin + Placebo)
    Heart Failure with Reduced Ejection Fraction
  • Experimental: Cohort B (Empagliflozin + Placebo)
    Heart Failure with Preserved Ejection Fraction

Primary Outcome Measure

Change From Baseline to Week 12 in PCr/ATP Ratio in the Resting State Measured by 31P Cardiac Magnetic Resonance Spectroscopy (MRS). [ Time Frame: At baseline and at week 12. ]

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