Clinical trial

eHealth Lifestyle Intervention To Enhance Outcomes in HFpEF

Opening soon · Not applicable · 1 countries · Registry ID NCT07661732

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionHeart Failure and Preserved Ejection Fraction, Obesity & Overweight, Heart Failure

Full registry criteria

Inclusion Criteria: * 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 * Elevated NT-proBNP according to the European Society of Cardiology age-adjusted rule-in thresholds: 125 pg/mL or higher if under 50 years, 250 pg/mL or higher if 50 to 75 years, and 500 pg/mL or higher if 75 years or older * Echocardiographic abnormalities: left ventricular hypertrophy, left atrial enlargement, or diastolic dysfunction Exclusion Criteria: * 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 * Inability to exercise

Treatments and study arms

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.

Primary outcomes

Change in peak oxygen uptake (VO2max)Baseline and 6 months

Change from baseline in peak oxygen uptake (VO2max, mL/kg/min) measured by cardiopulmonary exercise testing (cardiopulmonary exercise testing, CPET). Higher values indicate greater functional capacity. The between-group difference in change is analyzed by ANCOVA adjusted for the baseline value.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

IMIBIC🇪🇸 Córdoba, Córdoba, Spain

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José C Garrido GraciaContact

Email · Call +34 677 906 567

Manuel Cabello Terrón, MDPrincipal Investigator

José López Aguilera, MD PhDPrincipal Investigator