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

Jacob Moller

Status and phase: Completed; Phase 2

Conditions: Obesity; Heart Failure

Treatments: Drug: Placebo; Drug: Empagliflozin 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05042973

S-20210028-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 165 patients

Sex: All

Ages: 60 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

165 participants in 2 patient groups, including a placebo group

Active drug (Empagliflozin)

Active Comparator group

Description:

Empagliflozin 10 mg, 1 capsule per day

Treatment:

Drug: Empagliflozin 10 MG

Inactive drug (placebo)

Placebo Comparator group

Description:

Placebo, 1 capsule per day

Treatment:

Drug: Placebo