Clinical trial NCT05042973: The Metabolic Effects of Empagliflozin in Patients With High Risk of Heart Failure
Official title: Empagliflozin to Elderly and Obese Patients With Cardiovascular Disease (Empire Prevent: Metabolic): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Heart Failure
Keywords: Renal function
Glucose intolerance
Lipid metabolism
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Heart Foundation
name: Herlev and Gentofte Hospital
name: University Hospital Bispebjerg and Frederiksberg
name: Hillerod Hospital, Denmark
name: Rigshospitalet, Denmark
First posted: 2021-09-13
Enrollment: 165
Sex: ALL
Minimum age (years): 60
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ventricular epicardial adipose tissue (EAT) mass
timeFrame: 180 days
measure: Estimated extracellular volume (eECV)
timeFrame: 180 days
Secondary outcomes:
measure: Total pericardial adipose tissue volume
timeFrame: 180 days
measure: Total epicardial adipose tissue (EAT) volume
timeFrame: 180 days
measure: Plasma volume
timeFrame: 180 days
measure: Right ventricular end-diastolic volume index, RVEDVI
timeFrame: 180 days
Other outcomes:
measure: Erythropoietin
timeFrame: 180 days
measure: Exploratory outcome: fat tissue gene expression
timeFrame: 180 days
measure: Exploratory outcome: oxidative stress and inflammation.
timeFrame: 180 days
measure: Ketone bodies
timeFrame: 180 days
measure: Urine albumin/creatinine ratio
timeFrame: 180 days
measure: Uric acid
timeFrame: 180 days
measure: Kidney function (estimated)
timeFrame: 180 days
measure: Kidney function (measured)
timeFrame: 180 days
measure: Glucose tolerance
timeFrame: 180 days
measure: Body composition
timeFrame: 180 days
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Herlev-Gentofte Hospital
name: Morten Schou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Jacob Eifer Møller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: