NCT07251361Enrolling by invitation
Effects of a Multicomponent Training Program on Cardiac Function, Skeletal Muscle Metabolism, Functional Capacity, and Quality of Life in Patients With HFpEF: SENSORFIT-4HEART Study
SENSORFIT-4HEART: Smart Exercise preScriptiOn and Remote Monitoring FITness Platform for HEART Failure With Preserved Ejection Fraction
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
Heart failure with preserved ejection fraction (HFpEF) is a complex syndrome with increasing incidence and poor prognosis, accounting for up to 50% of heart failure cases. It is strongly associated with aging, cardiovascular risk factors (hypertension, diabetes, obesity), and is more prevalent in women than men. Patients with HFpEF frequently present with dyspnea, debilitating fatigue, poor quality of life, frequent hospitalizations, and high mortality rates. This study aims to evaluate the effects of a structured exercise program on cardiac function, skeletal muscle metabolism, functional capacity, and quality of life in patients with HFpEF, and to explore whether these benefits are mediated by circulating exerkines.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 23 Sept 2025
- Start date
- 20 Jan 2025
- Primary completion date
- 1 Feb 2025
- Lead sponsor
- Universidad Pública de Navarra
- Diseases
- Heart failure
- NCT number
- NCT07251361
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 20 Jan 2025 to the primary completion date, 1 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participation in cardiac rehabilitation within the past 12 months.
- Significant pulmonary disease, including primary pulmonary hypertension.
- Severe chronic lung disease, including COPD requiring home oxygen, chronic nebulizer therapy, long-term oral steroids, or hospitalization for decompensated pulmonary disease within the past 12 months.
- Inability to comprehend study information or complete questionnaires (e.g., psychiatric disorder, dementia).
Lab values
- Hemoglobin \<10 g/dL.
Other
- Contraindications to physical exercise training.
- Alternative diagnoses that could explain symptoms of HF (dyspnea, fatigue), in the judgment of the cardiologist.
- Body mass index (BMI) \>40 kg/m².
- Inability to perform a valid baseline cardiopulmonary exercise test
Who the study is looking for
- Patients diagnosed with heart failure with preserved ejection fraction according to 2021 ESC guidelines for Heart Failure.
- Left ventricular ejection fraction (LVEF) \>40%, and/or evidence of structural and/or functional cardiac abnormality (diastolic dysfunction, elevated filling pressures, BMI\>30 kg/m2)
- Elevated natriuretic peptides (BNP ≥35 pg/mL or NT-proBNP ≥125 pg/mL)
- Stable symptomatic heart failure patients (New York Heart Association functional class II-III/IV) during the last month
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidad Pública de Navarra (UPNA) Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.