eHealth Lifestyle Intervention To Enhance Outcomes in HFpEF

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaimónides Biomedical Research Institute of Córdoba

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

52 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Maimónides Biomedical Research Institute of Córdoba

Lead sponsor

Sociedad Andaluza de Cardiología

Collaborator