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

NCT07251361 | Enrolling By Invitation DMC

• 1 other identifier: PI_2023/146
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF)

Keywords

Exercise; PeakVO2; Cardiac function; Skeletal muscle bioenergetics; Quality of life; Exerkines

Outcome Measures

Primary Outcomes (1)

• Peak oxygen consumption

  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.

  Baseline and 12-week

Secondary Outcomes (23)

• Lean mass (kg)

  Baseline and 12-week

• Changes in blood pressure

  Baseline and 12-week

• Changes in Heart rate

  Baseline and 12-week

• Changes in muscle strength

  Baseline and 12-week

• Changes in quality of life

  Baseline and 12-week

Other Outcomes (3)

• Lipidomic

  Baseline and 12-week

• Mitochondrial leak respiration

  Baseline and 12-week

• Proteome profile

  Baseline and 12-week

Study Arms (2)

Supervised exercise program

EXPERIMENTAL

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.

Behavioral: Supervised training

Usual care

NO INTERVENTION

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

Interventions

Supervised training BEHAVIORAL

Supervised training

Supervised exercise program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad Pública de Navarra: lead
• NavarraBiomed Biomedical Research Center: collaborator
• Centro de Investigación Médica Aplicada (CIMA): collaborator
• Complejo Hospitalario de Navarra: collaborator
• Instituto de Investigación Sanitaria de Navarra (IdiSNA): collaborator

Study Sites (1)

Universidad Pública de Navarra (UPNA)

Pamplona, Navarre, 31010, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: November 26, 2025
• Study Start: January 20, 2025
• Primary Completion: February 1, 2025
• Study Completion (Estimated): December 20, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)