eHealth Lifestyle Intervention To Enhance Outcomes in HFpEF

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.

Conditions

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

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.

Sponsors & Collaborators

• Sociedad Andaluza de Cardiología

  collaborator UNKNOWN

• Maimónides Biomedical Research Institute of Córdoba

  lead OTHER

Principal Investigators

• Manuel Cabello Terrón, MD · H. Universitario Reina Sofía de Córdoba

• José López Aguilera, MD PhD · H. Universitario Reina Sofía de Córdoba / IMIBIC

• Rafael Gonzalez-Manzanares, MD PhD · H. Universitario Reina Sofía de Córdoba / IMIBIC / CIBERCV / CNIC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2028-12-31

Completion

2029-06-30

Countries

• Spain

Study Locations