eHealth Lifestyle Intervention To Enhance Outcomes in HFpEF

Sponsor
Maimónides Biomedical Research Institute of Córdoba
Study ID
NCT07661732
Status
Not Yet Recruiting

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Conditions

  • Heart Failure
  • Heart Failure and Preserved Ejection Fraction
  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Digital lifestyle education program — BEHAVIORAL
    Access to a study-specific web platform delivering structured healthy-lifestyle content as short videos (5 to 10 minutes) in thematic modules that unlock weekly over 6 months, covering adapted physical exercise, Mediterranean-diet-based healthy eating, and psychoemotional support.
  • Usual Care — OTHER
    Standard lifestyle recommendations provided during routine cardiology consultation, without access to the study web platform. Both groups continue guideline-directed medical therapy for HFpEF.

Study Details

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.

Key Dates

First listed
Jun 22, 2026
Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Digital lifestyle intervention
    Access to the study web platform with weekly lifestyle education modules, plus guideline-directed HFpEF therapy.
  • Active Comparator: Usual care
    Standard lifestyle recommendations given during routine consultation, plus guideline-directed HFpEF therapy.

Primary Outcome Measure

Change in peak oxygen uptake (VO2max) [ Time Frame: Baseline and 6 months ]

Central Contacts

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