NCT05084235CompletedPhase 2
The Cardiac Effects of Empagliflozin in Patients With High Risk of Heart Failure
Empagliflozin to Elderly and Obese Patients With Cardiovascular Disease (Empire Prevent: Cardiac): A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 29 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 191 (actual)
- First submitted
- 3 Sept 2021
- Start date
- 2 Sept 2021
- Primary completion date
- 16 Jan 2025
- Lead sponsor
- Jacob Moller
- Diseases
- Heart failure, Obesity
- NCT number
- NCT05084235
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 191
- From 2 Sept 2021 to the primary completion date, 16 Jan 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diabetes mellitus type 1 or 2 (no medical history, no antidiabetic treatment)
- Dementia
- Severe chronic obstructive pulmonary disease (FEV1\<50% expected value)
- Severe peripheral artery disease
- Cancer treatment within one year beside prostate cancer and basal cell carcinoma
- Severe aortic or mitral valve disease
Lab values
- Heart failure with reduced ejection fraction (LVEF \<40%)
- GFR \<30 ml/min/1,73m2
Other
- Inability to perform exercise test
- Severe non-compliance
- Substance abuse
- Permanent atrial fibrillation
- Pregnancy or breastfeeding
- Acute hospital admission within 30 days
- Participation in other pharmacological study
Who the study is looking for
- 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)
Age in the registry: 60 years to 84 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Herlev Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.