eHealth Lifestyle Intervention To Enhance Outcomes in HFpEF (NCT07661732) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
eHealth Lifestyle Intervention To Enhance Outcomes in HFpEF
Spain52 participantsStarted 2026-09-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Body mass index (BMI) over 40 kg/m²
* Life expectancy of less than 1 year
* Chronic kidney disease on renal replacement therapy
* Moderate or greater valvular heart disease
* Inability to exercise
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in peak oxygen uptake (VO2max)
Timeframe: Baseline and 6 months
2
Change in peak oxygen uptake (VO2max)
Timeframe: Baseline and 6 months
Trial details
NCT IDNCT07661732
SponsorMaimónides Biomedical Research Institute of Córdoba