NCT07661732Not yet recruiting
eHealth Lifestyle Intervention To Enhance Outcomes in HFpEF
Randomized Trial Of A Digital Lifestyle Education Strategy In Patients With Heart Failure And Overweight Or Obesity: The ELITE-HFpEF Study
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn if a digital lifestyle education program improves exercise capacity in adults who have heart failure with preserved ejection fraction (HFpEF) and overweight or obesity. HFpEF is a type of heart failure in which the heart muscle is stiff and does not relax well, even though its pumping strength looks normal. The main questions it aims to answer are: * Does the program improve how much oxygen participants can use during exercise, a measure of fitness, after 6 months? * Does the program improve participants' quality of life and help them lose weight? Researchers will compare a group that uses the digital program plus usual care to a group that receives usual care alone. This will show whether the program adds a benefit. Participants will: * Be placed by chance into one of the two groups * Use a study website with short videos on exercise, healthy eating, and managing stress (program group), with new content every week for 6 months * Have exercise tests, an ultrasound scan of the heart, blood tests, and complete a quality-of-life questionnaire at the start and after 6 months Both groups will keep taking their usual heart failure medicines.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 11 Jun 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Diseases
- Heart failure, Obesity
- NCT number
- NCT07661732
What you commit to
- Study type: Interventional
- Planned participants: 52
- From 1 Sept 2026 to the primary completion date, 31 Dec 2028
- 1 site 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
- Chronic kidney disease on renal replacement therapy
- Moderate or greater valvular heart disease
Other
- Body mass index (BMI) over 40 kg/m²
- Life expectancy of less than 1 year
- Inability to exercise
Who the study is looking for
- Age over 18 years
- Body mass index (BMI) over 27 kg/m²
- Symptoms consistent with heart failure
- Left ventricular ejection fraction (LVEF) of 50% or higher
- Elevated NT-proBNP according to the European Society of Cardiology age-adjusted rule-in thresholds: 125 pg/mL or higher if under 50 years, 250 pg/mL or higher if 50 to 75 years, and 500 pg/mL or higher if 75 years or older
- Echocardiographic abnormalities: left ventricular hypertrophy, left atrial enlargement, or diastolic dysfunction
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IMIBIC Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.