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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Digital lifestyle education program
BehavioralAccess 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 interventionStandard lifestyle recommendations provided during routine cardiology consultation, without access to the study web platform. Both groups continue guideline-directed medical therapy for HFpEF.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Digital lifestyle interventionExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in peak oxygen uptake (VO2max)
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.
Time frame
Baseline and 6 months2
Change in peak oxygen uptake (VO2max)
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.
Time frame
Baseline and 6 monthsSecondary outcomes
1
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score
Change from baseline in the KCCQ overall summary score, a patient-reported measure of heart failure-related health status. Scores range from 0 to 100; higher scores indicate better health status and quality of life.
Time frame
Baseline and 6 months2
Percent change in body weight
Percent change from baseline in body weight (kilograms) at 6 months.
Time frame
Baseline and 6 months3
Worsening heart failure
Number of participants with a worsening heart failure event, defined as hospitalization for decompensated heart failure or an outpatient or day-hospital visit requiring intravenous diuretic therapy.
Time frame
6 months4
All-cause mortality
Number of participants who die from any cause during follow-up.
Time frame
6 monthsOther outcomes
1
Change in VE/VCO2 slope
Change from baseline in the minute ventilation to carbon dioxide production (VE/VCO2) slope on cardiopulmonary exercise testing. Unit of Measure: ratio.
Time frame
Baseline and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Maimónides Biomedical Research Institute of Córdoba
Lead sponsor
Sociedad Andaluza de Cardiología
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: