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

Phase 2

Completed

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

• Registration Number: NCT05042973
• Lead Sponsor: Jacob Moller

Brief Summary

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.

Detailed Description

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

The Empire Prevent: Metabolic is designed to enroll at least 120 patients.

Study Timeline

• Study Start: 2021-09-02
• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-13
• Status Verified: 2025-01
• Primary Completion: 2025-01-16
• Study Completion: 2025-01-23
• Last Update Submitted: 2025-01-26
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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
Inactive drug (placebo)	Placebo	Placebo, 1 capsule per day
Active drug (Empagliflozin)	Empagliflozin 10 MG	Empagliflozin 10 mg, 1 capsule per day

Primary Outcome Measures

Name	Time	Method
Ventricular epicardial adipose tissue (EAT) mass	180 days	Between-group difference in the change of EAT mass assessed by cardiac magnetic resonance imaging (MRI)
Estimated extracellular volume (eECV)	180 days	Between-group difference in the change of eECV assessed by 99mTc-DTPA clearance (technetium-99mTc-diethylenetriaminepentaacetic acid)

Secondary Outcome Measures

Name	Time	Method
Total pericardial adipose tissue volume	180 days	Between-group difference in the change of pericardial adipose tissue volume assessed by cardiac MRI
Total epicardial adipose tissue (EAT) volume	180 days	Between-group difference in the change of EAT mass assessed by cardiac magnetic resonance imaging (MRI)
Plasma volume	180 days	Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin
Right ventricular end-diastolic volume index, RVEDVI	180 days	Between-group difference in the change of RVEDVI assessed by cardiac MRI

Trial Locations

Locations (2)

Herlev Hospital; 🇩🇰 Herlev, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark