The Cardiac 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: Empagliflozin 10 MG

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05084235

S-20210028-1

Details and patient eligibility

About

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.

Full description

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

Enrollment

191 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