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

Phase 2

Completed

• Conditions: Heart Failure; Obesity
• Interventions: Drug: Empagliflozin 10 MG; Drug: Placebo

• Registration Number: NCT05084235
• Lead Sponsor: Jacob Moller

Brief 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.

Detailed Description

The Empire Prevent: Cardiac is a part of the Empire Prevent Trial Program, which also comprises the Empire Prevent: Metabolic

Study Timeline

• Study Start: 2021-09-02
• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-19
• Status Verified: 2025-01
• Primary Completion: 2025-01-16
• Study Completion: 2025-01-16
• Last Update Submitted: 2025-01-26
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

• Body mass index >28kg/m2
• Age 60-84 years
• Established risk factor for developing heart failure, defined as at least one of the following:
• hypertension
• ischemic heart disease
• stroke/transient cerebral ischemia
• chronic kidney disease (eGFR 30-45ml/min/1.73m2)

Exclusion Criteria

• Diabetes mellitus type 1 or 2 (no medical history, no antidiabetic treatment)
• Heart failure with reduced ejection fraction (LVEF <40%)
• Inability to perform exercise test
• Dementia
• Severe non-compliance
• Substance abuse
• Severe chronic obstructive pulmonary disease (FEV1<50% expected value)
• Permanent atrial fibrillation
• GFR <30 ml/min/1,73m2
• Severe peripheral artery disease
• Cancer treatment within one year beside prostate cancer and basal cell carcinoma
• Severe aortic or mitral valve disease
• Pregnancy or breastfeeding
• Acute hospital admission within 30 days
• Participation in other pharmacological study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empaglifloxin	Empagliflozin 10 MG	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Maximal oxygen consumption	180 days	Between-group difference in the change of maximal oxygen consumption (peak VO2) assessed by cardiopulmonary exercise test
Left ventricular mass index	180 days	Between-group difference in the change of left ventricular mass index (LVMI) assessed by cardiac magnetic resonance image

Secondary Outcome Measures

Name	Time	Method
Left ventricular volume	180 days	Between-group difference in the change of left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI) assessed by cardiac magnetic resonance image
Left ventricular function	180 days	Between-group difference in the change of first phase ejection fraction and left ventricular ejection fraction (LVEF) assessed by cardiac magnetic resonance image
Daily activity level	180 days	Between-group difference in the change of daily activity level assessed by accelerometer

Trial Locations

Locations (2)

Herlev Hospital; 🇩🇰 Herlev, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark