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

NCT ID: NCT07251361

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2026-12-20

Brief 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.

Detailed Description

Standard pharmacological treatments have shown limited prognostic benefit, highlighting the need for non-pharmacological strategies. Exercise training may represent an effective therapeutic tool, with potential to improve cardiac remodeling, skeletal muscle bioenergetics, exercise tolerance, and quality of life. Importantly, exerkines-molecules secreted by skeletal muscle and other organs in response to exercise-may mediate systemic beneficial effects by modulating metabolic, immuno-inflammatory, and growth pathways.

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Supervised exercise program

Participants assigned to this arm will receive supervised multicomponent exercise program delivered twice per week, combining resistance training (RT) with aerobic training within the same session. The RT session duration will increase progressively from 10 to 20 min at 40-70 % of one repetition maximum (1-RM) twice weekly. RT include progressively three series × 10-15 repetitions of leg press, knee extensors, chest press, and horizontal rowing.

Group Type: EXPERIMENTAL

Supervised training

Intervention Type: BEHAVIORAL

Supervised training

Usual care

Patients allocated to this arm will receive the usual care plus explicit recommendations for home-based aerobic and strength training (Vivifrail program).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Supervised training

Supervised training

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NavarraBiomed Biomedical Research Center

OTHER

Sponsor Role: collaborator

Centro de Investigación Médica Aplicada (CIMA)

UNKNOWN

Sponsor Role: collaborator

Complejo Hospitalario de Navarra

OTHER

Sponsor Role: collaborator

Instituto de Investigación Sanitaria de Navarra (IdiSNA)

UNKNOWN

Sponsor Role: collaborator

Universidad Pública de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Dr Mikel Izquierdo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad Pública de Navarra (UPNA)

Pamplona, Navarre, Spain

Countries

Spain

Other Identifiers

PI_2023/146

Identifier Type: OTHER

Identifier Source: secondary_id

PI_2023/146

Identifier Type: -

Identifier Source: org_study_id