The Cardiac Effects of Empagliflozin in Patients With High Risk of Heart Failure

Sponsor
Jacob Moller
Study ID
NCT05084235
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days
  • Placebo — DRUG
    Placebo matches the active drug in appearance, odor and labelling

Study Details

The aim of this trial is to assess the effect of Empagliflozin on cardiac mass, volumes, cardiac biomarkers, metabolism, daily activity level, health-related quality of life in patients in elderly and obese patients with increased risk of developing heart failure. The primary hypotheses are that 180 days of treatment with Empagliflozin 10 mg a day will: 1) reduce left ventricular mass index, and 2) increase peak VO2 (maximal oxygen consumption) compared with placebo.

Key Dates

Start date
Sep 2, 2021
Status verified
Jan 2025
Primary completion
Jan 16, 2025
Completion
Jan 16, 2025

Study Design

Enrollment
191 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Empaglifloxin
  • Placebo Comparator: Placebo

Primary Outcome Measure

Left ventricular mass index [ Time Frame: 180 days ]

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