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

Sponsor
Jacob Moller
Study ID
NCT05042973
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 lipid and glucose metabolism as well as volume homeostasis and renal function in elderly and obese patients with increased risk of developing heart failure. No history of established heart failure or diabetes is allowed. The primary hypotheses are that 6 months treatment with Empagliflozin 10 mg a day will: 1) decrease epicardial adipose tissue volume, and 2) reduce estimated extracellular volume compared with placebo.

Key Dates

Start date
Sep 2, 2021
Status verified
Jan 2025
Primary completion
Jan 16, 2025
Completion
Jan 23, 2025

Study Design

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

Arms

  • Active Comparator: Active drug (Empagliflozin)
    Empagliflozin 10 mg, 1 capsule per day
  • Placebo Comparator: Inactive drug (placebo)
    Placebo, 1 capsule per day

Primary Outcome Measure

Ventricular epicardial adipose tissue (EAT) mass [ Time Frame: 180 days ]

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