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

NCT05084235 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2025-01-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Empagliflozin 10 MG

Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days

DRUG

Placebo

Placebo matches the active drug in appearance, odor and labelling

Sponsors & Collaborators

  • Danish Heart Foundation

    collaborator OTHER

  • Herlev and Gentofte Hospital

    collaborator OTHER

  • University Hospital Bispebjerg and Frederiksberg

    collaborator OTHER

  • Hillerod Hospital, Denmark

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Jacob Moller

    lead OTHER

Principal Investigators

  • Jacob Eifer Møller, MD, PhD, · Odense University Hospital

  • Morten Schou, MD, PhD, DmSc · Herlev-Gentofte Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-02
Primary Completion
2025-01-16
Completion
2025-01-16

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05084235 on ClinicalTrials.gov