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Enrolling by invitation NCT07251361

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

No phase Interventional Heart Failure With Preserved Ejection Fraction (HFPEF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Supervised training.
Who it may be relevant to
Registry conditions: Heart Failure With Preserved Ejection Fraction (HFPEF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

SENSORFIT-4HEART: Smart Exercise preScriptiOn and Remote Monitoring FITness Platform for HEART Failure With Preserved Ejection Fraction

Overview

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.

Interventions

  • Behavioral Supervised training
    Supervised training

Primary outcome measures

  • Peak oxygen consumption [Time frame: Baseline and 12-week]
Secondary outcome measures (12)
  • Lean mass (kg) [Time frame: Baseline and 12-week]
  • Changes in blood pressure [Time frame: Baseline and 12-week]
  • Changes in Heart rate [Time frame: Baseline and 12-week]
  • Changes in muscle strength [Time frame: Baseline and 12-week]
  • Changes in quality of life [Time frame: Baseline and 12-week]
  • Physical activity and sedentary behaviour (in minutes) [Time frame: Baseline and 12-week]
  • Pittsburgh Sleep Quality Index [Time frame: Baseline and 12-week]
  • Epidemiological Studies-Depression Scale questionnaire [Time frame: Baseline and 12-week]
  • Cognitive Function [Time frame: Baseline and 12-week]
  • Adherence to the Mediterranean Diet [Time frame: Baseline and 12-week]
  • Psychological Distress [Time frame: Baseline and 12-week]
  • Haematology [Time frame: Baseline and 12-week]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

Spain · 1 center
  • Universidad Pública de Navarra (UPNA) — Pamplona

Identifiers

NCT: NCT07251361 · PI_2023/146 · PI_2023/146

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗