Heart Failure, Obesity
Conditions
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
Interventions
DRUGEmpagliflozin 10 MG
Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days
DRUGPlacebo
Placebo matches the active drug in appearance, odor and labelling
Sponsors
Danish Heart Foundation
Herlev and Gentofte Hospital
University Hospital Bispebjerg and Frederiksberg
Hillerod Hospital, Denmark
Rigshospitalet, Denmark
Jacob Moller
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular mass index | 180 days | Between-group difference in the change of left ventricular mass index (LVMI) assessed by cardiac magnetic resonance image |
| Maximal oxygen consumption | 180 days | Between-group difference in the change of maximal oxygen consumption (peak VO2) assessed by cardiopulmonary exercise test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily activity level | 180 days | Between-group difference in the change of daily activity level assessed by accelerometer |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Left atrium size | 180 days | Between-group difference in the change of left atrial maximal and minimal size measured by cardiac magnetic resonance image |
| Global strain | 180 days | Between-group difference in the change of global strain assessed by cardiac magnetic resonance image |
| Growth differentiation factor 15 | 180 days | Between-group difference in the change of the biomarker growth differentiation factor 15 (pg/ml) |
| Cardiac fibrosis | 180 days | Between-group difference in the change of cardiac fibrosis assessed by cardiac magnetic resonance image |
| Left atrium function | 180 | Between-group difference in the change of left atrial emptying fraction and left atrium ejection fraction assessed by cardiac magnetic resonance image |
| Biomarkers of heart disease | 180 days | Between-group difference in the change of biomarkers of heart disease, including atrial natriuretic peptide (ANP), brain (B-type) natriuretic peptide (BNP), and N-terminal pro-hormone BNP (NT-proBNP). All measured as pmol/L. |
| Quality-of-life scores | 180 days | Between-group difference in the change of self-reported quality of life assessed by the 36-item short form health survey (SF-36 questionnaire). The SF-36 targets eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a scale from 0 to 100, with a higher score representing a more favorable health state. An average score is calculated for each health concept. |
| Blood pressure | 180 days | Between-group difference in the change of systolic and diastolic blood pressure assessed by ambulatory blood pressure measurement |
| Wall stress | 180 days | Between-group difference in the change of estimated end-systolic wall stress (ESWS). ESWS will be calculated from results of multimodality imaging combining MRI and echocardiography by using a formula incorporating MRI LV end-systolic diameter and wall thickness as well as echocardiographic mean and arterial blood pressure as proposed by Reichek et al. based on the Law of Laplace. (please see references Reichek et al and Carter-Storch et al. in the reference list) |
Countries
Denmark
Outcome results
None listed