An interventional study of Telerehabilitation in Heart Failure With Preserved Ejection Fraction, sponsored by American Heart of Poland. Recruiting at 3 sites in Poland. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by American Heart of Poland · Not applicable, Interventional, and Treatment
Heart failure with preserved ejection fraction (HFpEF) is characterized by typical symptoms of heart failure, structural and functional cardiac abnormalities, and elevated serum levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP), despite preserved left ventricular ejection fraction. Typical symptoms of HFpEF include reduced exercise tolerance, exertional dyspnea, paroxysmal nocturnal dyspnea, and orthopnea.
It is estimated that approximately 35 million people worldwide suffer from HFpEF, including approximately 3 million patients in the United States. The exact number of patients with HFpEF remains unknown; however, the prevalence of the disease is increasing. Risk factors for HFpEF include obesity, arterial hypertension, atrial fibrillation, diabetes mellitus, dyslipidemia, and advanced age. Patients with HFpEF are hospitalized an average of 1.4 times per year, and the annual mortality rate is approximately 15%. To date, the most effective approach to the management of HFpEF has been the control of comorbidities, including diabetes mellitus, arterial hypertension, coronary artery disease, and obesity.
Remote rehabilitation (RR) has already become an established component of modern cardiology. It is widely used in developed countries, and its popularity continues to increase. Its main advantages include reduced costs for both patients and healthcare payers compared with traditional, center-based rehabilitation. In addition, for patients living far from rehabilitation centers or those with limited access to transportation, remote rehabilitation provides a solution to improve access to care.
The efficacy and safety of remote rehabilitation have been demonstrated in cardiac patients with coronary artery disease and in patients with heart failure with reduced ejection fraction (HFrEF). However, to date, the safety and efficacy of remote rehabilitation in patients with HFpEF have not been sufficiently investigated. Therefore, the aim of the proposed study is to assess the safety and efficacy of remote rehabilitation in patients with HFpEF.
Heart Failure with Preserved Ejection Fraction (HFpEF) is an increasing challenge. HFpEF is primarily associated with significant limitations in exercise tolerance due to feelings of breathlessness and shortness of breath. As the disease progresses, the severity of symptoms deepens, preventing normal functioning and significantly limiting daily activities-such as shopping, cleaning, walking, or socializing. These symptoms are associated with a significant decline in quality of life. Moreover, HFpEF is characterized by the need for recurring hospitalizations and frequent outpatient visits to specialists, which significantly burdens the healthcare system. Patients suffering from HFpEF also have a significantly increased risk of death compared to the healthy population. Pharmacotherapy for HFpEF offers limited benefits; so far, only one drug has been proven to limit symptoms somewhat and reduce the risk of hospitalization, but it does not impact mortality; these are inhibitors of the sodium-glucose cotransporter 2. A more effective treatment form for this patient group is cardiac rehabilitation. However, this involves very large financial outlays and is often impossible for logistical reasons. Moreover, rehabilitation cannot be conducted all the time. A solution to this problem could be home rehabilitation, which is much cheaper and more accessible, and the patient can use it for a long time. Given the above, the study aims to assess the safety and effectiveness of home rehabilitation in patients with HFpEF. The study is designed as a randomized, blinded, multicenter trial in which 110 patients diagnosed with HFpEF will be included. Each arm will include 55 patients diagnosed with HFpEF based on the European Society of Cardiology (ESC) definition of 2021. Each patient qualifying for the study will have a stress test on a cycle ergospirometer, a panel of laboratory tests including both a basic panel and the concentration of selected adipokines and inflammatory markers in serum blood and the quality of life will be assessed. Additionally, coronary microcirculation will be performed. Based on the stress test on the cycle ergometer, the training load for the time of home rehabilitation will be determined. Then, a bicycle ergometer and a set of sensors for telerehabilitation will be delivered to the patient's home, and the study participant will be trained in its use. Then, for 12 weeks, the study group will have four weekly home rehabilitation sessions with remote care.
The control group of 55 patients will be treated according to standard therapy. After 12 weeks, all participants will again undergo the stress test on the ergospirometer, an analogous set of initial laboratory tests, and an assessment of quality of life. Patients will again have performed an assessment of coronary microcirculation. An independent team will assess any adverse event to ensure the safety of home rehabilitation.
The endpoints in the proposed study will be the evaluation of physical performance parameters obtained during ergospirometry, left ventricle filling parameters, and the quality of life of patients. Appropriately conducted home rehabilitation can significantly improve the performance of patients with HFpEF assessed in the stress test; moreover, parameters of left ventricle filling will also improve. Improving these parameters has a proven impact on reducing the risk of death, frequency of hospitalizations, and quality of life of patients with HFpEF.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 110 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →American Heart of Poland is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment recommendations in accordance with the updated 2023 ESC Guidelines + remote rehabilitation + telemonitoring using telemedicine tools (ECG telemetry during exercise, an SOS wristband, and a blood pressure monitor).
Other: Telerehabilitation
Treatment recommendations in accordance with the updated 2023 ESC Guidelines + telemonitoring using telemedicine tools (SOS wristband and blood pressure monitor). Patients will be treated according to standard therapy.
A bicycle ergometer and a set of sensors for telerehabilitation will be delivered to the patient's home, and the study participant will be trained in its use. Then, for 12 weeks, the study group will have four weekly home rehabilitation sessions with remote care.
Efficacy
Assessment of the efficacy of remote rehabilitation in patients with heart failure with preserved ejection fraction (HFpEF), assessed by the change in peak oxygen uptake (peak VO₂) measured by cardiopulmonary exercise testing (CPET) over a 3-month follow-up period.
Time frame: through study completion, an average of four months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Assessment of the safety of remote rehabilitation in patients with heart failure with preserved ejection fraction (HFpEF).
Time frame: through study completion, an average of four months
Excercise capacity
Assessment of exercise capacity using the 6-minute walk test (6MWT).
Time frame: through study completion, an average of four months
NT-proBNP
Assessment of serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels.
Time frame: through study completion, an average of four months
Quality of life (Kansas City Cardiomyopathy Questionnaire)
Assessment of patients' quality of life using the Kansas City Cardiomyopathy Questionnaire, where minimum value is 0 and maximum value is 100; higher scores mean: better outcome (fewer heart failure symptoms, fewer physical and social limitations, and better quality of life).
Time frame: through study completion, an average of four months
Quality of life (EuroQol-5D
Assessment of patients' quality of life using the EuroQol-5D questionnaire, where minimum value is 0 and maximum value is 100; higher scores mean: better health status and health-related quality of life
Time frame: through study completion, an average of four months
Level of adipokines
Percentage change in serum concentrations of adipose tissue-derived hormones: leptin, visfatin, adiponectin, resistin, omentin, and apelin measured in ng/mL.
Time frame: through study completion, an average of four months
Level of inflammatory markers measured in ng/mL.
Percentage change in serum concentrations of oxidative stress and inflammatory markers: Myeloperoxidase, calprotectin, symmetric and asymmetric dimethylarginine (SDMA, ADMA), arginine measured in ng/mL.
Time frame: through study completion, an average of four months
Liver elastography
Liver stiffness will be assessed by elastography and reported as the median of 10 measurements. Unit of Measure: kPa.
Time frame: through study completion, an average of four months
Level of inflammatory markers measured in mg/mL.
Percentage change in serum concentrations of oxidative stress and inflammatory markers: hsCRP, indoxyl sulfate and trimethylamine N-oxide (TMAO) measured in mg/mL.
Time frame: through study completion, an average of four months
Level of inflammatory marker measured in mU/mL.
Percentage change in serum activity of oxidative stress and inflammatory marker: myeloperoxidase measured in mU/mL.
Time frame: through study completion, an average of four months
Level of inflammatory marker measured in mg/dl
Percentage change in serum concentrations of oxidative stress and inflammatory marker: uric acid measured in mg/dl.
Time frame: through study completion, an average of four months
Level of inflammatory markers measured in pg/ml
Percentage change in serum concentrations of oxidative stress and inflammatory marker: interleukin 6 measured in pg/ml
Time frame: through study completion, an average of four months
Index of Microcirculatory Resistance (IMR)
The Index of Microcirculatory Resistance (IMR) will be assessed during invasive coronary physiological evaluation using a pressure- and temperature-sensing coronary guidewire. IMR will be defined as the product of distal coronary pressure and the mean transit time of a saline bolus during maximal hyperemia, measured using a dual-function pressure- and temperature-sensing guidewire. IMR is a specific index reflecting coronary microvascular function.
Time frame: through study completion, an average of four months
Coronary Flow Reserve (CRF)
Coronary flow reserve (CFR) will be assessed during invasive coronary physiological evaluation using a pressure- and temperature-sensing coronary guidewire. CFR will be defined as the ratio of maximal to baseline coronary blood flow. It will measure the capacity of both the epicardial artery and the microvascular resistance vessels to facilitate blood flow.
Time frame: through study completion, an average of four months
Plan to share: Undecided
Started Sep 2025 (actual). Primary completion is estimated for Nov 2029, 50 months after the start.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 50 months is above that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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American Heart of Poland