eHealth Lifestyle Intervention To Enhance Outcomes in HFpEF
ELITE-HFpEF
Randomized Trial Of A Digital Lifestyle Education Strategy In Patients With Heart Failure And Overweight Or Obesity: The ELITE-HFpEF Study
1 other identifier
interventional
52
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2026
CompletedFirst Posted
Study publicly available on registry
June 22, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
Study Completion
Last participant's last visit for all outcomes
June 30, 2029
June 22, 2026
June 1, 2026
2.3 years
June 11, 2026
June 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline and 6 months
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.
Baseline and 6 months
Secondary Outcomes (7)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score
Baseline and 6 months
Percent change in body weight
Baseline and 6 months
Worsening heart failure
6 months
All-cause mortality
6 months
Change in fat mass
Baseline and 6 months
- +2 more secondary outcomes
Other Outcomes (1)
Change in VE/VCO2 slope
Baseline and 6 months
Study Arms (2)
Digital lifestyle intervention
EXPERIMENTALAccess to the study web platform with weekly lifestyle education modules, plus guideline-directed HFpEF therapy.
Usual care
ACTIVE COMPARATORStandard lifestyle recommendations given during routine consultation, plus guideline-directed HFpEF therapy.
Interventions
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.
Standard lifestyle recommendations provided during routine cardiology consultation, without access to the study web platform. Both groups continue guideline-directed medical therapy for HFpEF.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IMIBIC
Córdoba, Córdoba, 14004, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manuel Cabello Terrón, MD
H. Universitario Reina Sofía de Córdoba
- PRINCIPAL INVESTIGATOR
José López Aguilera, MD PhD
H. Universitario Reina Sofía de Córdoba / IMIBIC
- PRINCIPAL INVESTIGATOR
Rafael Gonzalez-Manzanares, MD PhD
H. Universitario Reina Sofía de Córdoba / IMIBIC / CIBERCV / CNIC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2026
First Posted
June 22, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
June 30, 2029
Last Updated
June 22, 2026
Record last verified: 2026-06