Heart Failure With Preserved Ejection Fraction (HFPEF)SENSORFIT-4HEANCT07251361
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
A study testing Supervised training in people with Heart Failure With Preserved Ejection Fraction (HFPEF), run by Universidad Pública de Navarra at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFPEF)
- What is being tested?
- Supervised training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2025to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SENSORFIT-4HEART: Smart Exercise preScriptiOn and Remote Monitoring FITness Platform for HEART Failure With Preserved Ejection Fraction
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.
Read the 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.
- Being tested
- Supervised training
- Keywords
- Exercise, PeakVO2, Cardiac function, Skeletal muscle bioenergetics, Quality of life, Exerkines
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised trainingBehavioural
Supervised training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12-week
Secondary outcomes (23)
Lean mass (kg)
Dual-energy X-ray absorptiometry (DXA) body composition measure
Measured: Baseline and 12-week
Changes in blood pressure
Systolic and diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Measured: Baseline and 12-week
Changes in Heart rate
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in pulses/min.
Measured: Baseline and 12-week
Changes in muscle strength
Grip strength of participants will be measured using a manual dynamometer and reported in kg. Pectoral press, bilateral leg-press, knee extension, and back press) will be measured using a eGYM machines and reported in kg
Measured: Baseline and 12-week
Changes in quality of life
We will use the EuroQol five-dimension five-level questionnaire (EQ-5D-5L) to assess health-related quality of life. The EQ-5D-5L includes five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on a 5-point scale ranging from 1 (no problems) to 5 (extreme problems). The responses are combined into an index value ranging from -0.594 to 1, where higher scores indicate a better health-related quality of life.
Measured: Baseline and 12-week
Physical activity and sedentary behaviour (in minutes)
Physical activity level objectively measured using Actigraph Accelerometry. This will be worn on the waist and will passively record physical activity and sedentary behavior.
Measured: Baseline and 12-week
Pittsburgh Sleep Quality Index
A 19-item self-report questionnaire that assesses subjective sleep quality and disturbances over the past month will be evaluated by Pittsburgh Sleep Quality Index. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline and 12-week
Epidemiological Studies-Depression Scale questionnaire
Depression levels will be assessed using the Center for Epidemiological Studies-Depression Scale (CES-D) questionnaire, which is validated and widely employed in cardiometabolic patients. The CES-D consists of 20 items, each rated on a 4-point Likert scale ranging from 0 (rarely or none of the time) to 3 (most or all of the time), assessing the frequency of depressive symptoms during the past week. The total score ranges from 0 to 60, with higher scores indicating greater depressive symptomatology.
Measured: Baseline and 12-week
Cognitive Function
Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a validated screening tool that evaluates multiple cognitive domains, including executive function, memory, attention, language, and visuospatial abilities. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance.
Measured: Baseline and 12-week
Adherence to the Mediterranean Diet
Adherence to the Mediterranean dietary pattern will be assessed using the Mediterranean Diet Adherence Screener (MEDAS), a validated 14-item questionnaire designed to evaluate compliance with key components of the Mediterranean diet. Each item is scored 0 or 1, depending on whether the dietary criterion is met, yielding a total score ranging from 0 to 14, where higher scores indicate greater adherence to the Mediterranean diet.
Measured: Baseline and 12-week
Psychological Distress
The Kessler Psychological Distress Scale (K10) will be used to assess nonspecific psychological distress, including symptoms of anxiety and depression, experienced over the past four weeks. The K10 consists of 10 items, each rated on a 5-point Likert scale ranging from 1 (none of the time) to 5 (all of the time), resulting in a total score between 10 and 50. Higher scores indicate greater psychological distress.
Measured: Baseline and 12-week
Haematology
Erythrocyte count (×10⁶ cells/µL), haematocrit (%), haemoglobin (g/dL), platelet count (×10³ cells/µL), leukocyte count (×10³ cells/µL), and erythrocyte mean corpuscular volume (fL) will be quantified using a Coulter haematology analyzer (Brand, City, Country).
Measured: Baseline and 12-week
Concentrations of circulating cytokines, adipokines, myokines, and bone metabolism biomarkers.
Plasma concentrations of pro-inflammatory and anti-inflammatory cytokines (IL-1β, IL-2, IL-6, IL-8, IL-10, IFN-γ, TNF-α, IL-1ra, and TNF sRII-α), adipokines (adiponectin, adipsin, resistin, PAI-1 active, insulin, and leptin), and myokines (irisin) will be quantified using Luminex xMAP technology. In addition, biomarkers related to bone metabolism (ACTH, DKK-1, FGF-23, osteocalcin, osteopontin [OPN], osteoprotegerin, PTH, and sclerostin [SOST]) will be measured with the same platform. Each analyte will be reported separately as an independent outcome, with concentrations expressed in pg/mL or ng/mL, as appropriate for the specific biomarker.
Measured: Baseline and 12-week
Resting energy expenditure
Resting energy expenditure is measured in the fasting and fed state by indirect calorimetry
Measured: Baseline and 12-week
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
N-terminal pro-B-type natriuretic peptide (NT-proBNP) will be quantified by standardized immunoassay (e.g., electrochemiluminescence immunoassay, ECLIA) following manufacturer's instructions
Measured: Baseline and 12-week
Lean mass index (kg/m2)
Dual-energy X-ray absorptiometry (DXA) body composition measure
Measured: Baseline and 12-week
Appendicular lean mass index (kg/m2)
Dual-energy X-ray absorptiometry (DXA) body composition measure
Measured: Baseline and 12-week
Fat mass index (kg/m2)
Dual-energy X-ray absorptiometry (DXA) body composition measure
Measured: Baseline and 12-week
Fat mass (kg)
Dual-energy X-ray absorptiometry (DXA) body composition measure
Measured: Baseline and 12-week
Visceral adipose tissue (kg)
Dual-energy X-ray absorptiometry (DXA) body composition measure
Measured: Baseline and 12-week
Lean mass/fat mass ratio
Dual-energy X-ray absorptiometry (DXA) body composition measure
Measured: Baseline and 12-week
Fat free mass
Dual-energy X-ray absorptiometry (DXA) body composition measure
Measured: Baseline and 12-week
Whole bone mineral density (g/cm2)
Dual-energy X-ray absorptiometry (DXA) body composition measure
Measured: Baseline and 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start20 Jan 2025
- Primary completion1 Feb 2025
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFPEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Pública de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- NavarraBiomed Biomedical Research Center, Centro de Investigación Médica Aplicada (CIMA), Complejo Hospitalario de Navarra, Fundación Instituto de Investigación Sanitaria de Navarra
- Responsible party
- Principal investigator, Dr Mikel Izquierdo, Universidad Pública de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251361
- Sponsor's protocol ID
- PI_2023/146
- Other IDs
- PI_2023/146
- Acronym
- SENSORFIT-4HEA
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SENSORFIT-4HEART: Smart Exercise preScriptiOn and Remote Monitoring FITness Platform for HEART Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT07251361
- Acronym / sponsor ID
- SENSORFIT-4HEA / PI_2023/146
- Keywords
- Exercise, PeakVO2, Cardiac function, Skeletal muscle bioenergetics, Quality of life, Exerkines
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidad Pública de NavarraUniversity, hospital or other
- Collaborators
- NavarraBiomed Biomedical Research Center, Centro de Investigación Médica Aplicada (CIMA), Complejo Hospitalario de Navarra, Fundación Instituto de Investigación Sanitaria de Navarra
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised exercise program | Experimental | Behavioral: Supervised trainingParticipants 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised trainingSupervised training | Behavioural | Supervised exercise program |
Primary outcome
Peak oxygen consumption
Time frame: 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.
23 secondary outcomes
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
Concentrations of circulating cytokines, adipokines, myokines, and bone metabolism biomarkers.
Time frame: Baseline and 12-week
Resting energy expenditure
Time frame: Baseline and 12-week
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame: Baseline and 12-week
Lean mass index (kg/m2)
Time frame: Baseline and 12-week
Appendicular lean mass index (kg/m2)
Time frame: Baseline and 12-week
Fat mass index (kg/m2)
Time frame: Baseline and 12-week
Fat mass (kg)
Time frame: Baseline and 12-week
Visceral adipose tissue (kg)
Time frame: Baseline and 12-week
Lean mass/fat mass ratio
Time frame: Baseline and 12-week
Fat free mass
Time frame: Baseline and 12-week
Whole bone mineral density (g/cm2)
Time frame: Baseline and 12-week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised training in people with Heart Failure With Preserved Ejection Fraction (HFPEF), run by Universidad Pública de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen consumption (time frame: Baseline and 12-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.