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NOT YET RECRUITING
NCT07661732
NA

eHealth Lifestyle Intervention To Enhance Outcomes in HFpEF

Sponsor: Maimónides Biomedical Research Institute of Córdoba

View on ClinicalTrials.gov

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.

Official title: Randomized Trial Of A Digital Lifestyle Education Strategy In Patients With Heart Failure And Overweight Or Obesity: The ELITE-HFpEF Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2026-09-01

Completion Date

2029-06-30

Last Updated

2026-06-22

Healthy Volunteers

No

Interventions

BEHAVIORAL

Digital lifestyle education program

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.

OTHER

Usual Care

Standard lifestyle recommendations provided during routine cardiology consultation, without access to the study web platform. Both groups continue guideline-directed medical therapy for HFpEF.

Locations (1)

IMIBIC

Córdoba, Córdoba, Spain