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
Heart Failure With Preserved Ejection Fraction (HFPEF)
Investigational drug(s) / intervention(s)
Supervised training
Supervised training: Supervised training
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* 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
Exclusion Criteria:
* Participation in cardiac rehabilitation within the past 12 months.
* Contraindications to physical exercise training.
* Alternative diagnoses that could explain symptoms of HF (dyspnea, fatigue), in the judgment of the cardiologist.
* 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.
* Hemoglobin \<10 g/dL.
* Body mass index (BMI) \>40 kg/m².
* Inability to perform a valid baseline cardiopulmonary exercise test
* Inability to comprehend study information or complete questionnaires (e.g., psychiatric disorder, dementia).
Primary outcome measure(s)
Peak oxygen consumption — Baseline and 12-week Changes in peak oxygen consumption between and within groups at 12-week Unit of measure of peak oxygen consumption: mL/kg/min. Maximal functional capacity will be evaluated using incremental and symptom-limited cardiopulmonary exercise testing on a bicycle ergometer, beginning with a workload of 25 W and increasing gradually in a ramp protocol at 25-W increments every 3 minute. We define maximal functional capacity as when the patient stops pedalling because of symptoms and the respiratory exchange ratio (RER) was \>1. Gas exchange data and cardiopulmonary variables were averages of values taken every 10 seconds. Peak oxygen consumption (PeakVO2) was defined as the highest value of VO2 during the last 20 seconds of exercise.
Trial sites (1)
Facility
City
Region
Status
Universidad Pública de Navarra (UPNA)
Pamplona
Navarre
More Universidad Pública de Navarra trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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