About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Digital lifestyle education program
- Usual Care
Treatment groups
Sponsors and collaborators
Maimónides Biomedical Research Institute of Córdoba
Lead sponsor
Sociedad Andaluza de Cardiología
Collaborator