Heart Failure With Preserved Ejection FractionPATRON-HFNCT07918209
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
A study testing Telerehabilitation in people with Heart Failure With Preserved Ejection Fraction, run by American Heart of Poland at 3 sites in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesPoland
- Study dates
- 30 Sep 2025to 31 Jul 2030
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of at least one of the following symptoms: dyspnea, orthopnea, paroxysmal nocturnal dyspnea, reduced exercise tolerance, fatigue, prolonged recovery time after exercise.
- Presence of at least one of the following findings on physical examination: elevated jugular venous pressure, hepatojugular reflux, audible third heart sound (S3), laterally displaced apical impulse.
- Presence of at least one of the following findings on transthoracic echocardiography: enlarged left atrium and/or left ventricle, E/e' ≥13, e' <9 cm/s.
- NT-proBNP >250 pg/mL or >600 pg/mL in patients with atrial fibrillation.
- Left ventricular ejection fraction (LVEF) ≥50%.
- Age >40 years.
- Ability to perform exercise on a bicycle ergometer with ECG monitoring.
- No contraindications to coronary angiography.
Who cannot join
- History of myocardial infarction, stroke, transient ischemic attack, or another major cardiovascular event within the previous 60 days.
- Microvascular angina, defined as exertional anginal chest pain in the absence of stenosis in the epicardial coronary arteries.
- Left ventricular ejection fraction (LVEF) <50%.
- Diagnosed cardiomyopathy, including infiltrative, storage, hypertrophic, or cardiomyopathy caused by a known reversible etiology.
- Constrictive pericarditis.
- Atrial fibrillation or atrial flutter with a heart rate >110 bpm at the first visit.
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- Blood pressure >180/110 mmHg.
- Acute decompensated heart failure.
- Chronic pulmonary disease requiring home oxygen therapy and/or oral corticosteroid therapy.
- Pulmonary hypertension.
- Liver transaminase levels >3 times the upper limit of the local reference range.
- Chronic kidney disease with eGFR <20 mL/min/1.73 m².
- Hemoglobin <9 mg/dL.
- Active malignancy or suspected malignancy.
- Alcohol use disorder or illicit drug use.
- Allergy to the adhesive or material used in the electrodes required for telemonitoring.
- In the investigator's opinion, the patient is unable to participate in the clinical trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland3 sites, 3 recruiting
- Recruiting
Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów
Chrzanów
Aleksander Żurakowski, MD, PhD, a.zurakowski@ahop.pl
Paulina Skalska, paulina.skalska@ahop.pl
- Recruiting
Telcor Medical Center Scanmed
Katowice
Krzysztof Kincel, kkincel@interia.pl
Wiktoria Skubisz, wiktoria.skubisz@ahop.pl
- Recruiting
Polish-American Heart Clinics X Department of Invasive Cardiology, Electrophysiology and Electrostimulation in Tychy
Tychy
Adam Janas, MD, PhD, adam.janas@ahop.pl
Małgorzata Gorgoń, malgorzata.gorgon@ahop.pl
About this study
Official title: A Multicenter, Randomized Research Experiment to Compare the Standard Care Model to a Rehabilitation Strategy Based on Remotely Monitored, Regular Training Using a Bicycle Ergometer in Patients With Heart Failure With Preserved Ejection Fraction (PATRON-HF)
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Telerehabilitation
- Keywords
- Heart Failure with Preserved Ejection Fraction, telerehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | 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). Receives: Other: Telerehabilitation |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: through study completion, an average of four months
Secondary outcomes (4)
Excercise capacity
Assessment of exercise capacity using the 6-minute walk test (6MWT).
Measured: through study completion, an average of four months
NT-proBNP
Assessment of serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels.
Measured: 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).
Measured: 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
Measured: through study completion, an average of four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start30 Sep 2025
- Primary completion30 Nov 2029 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Heart of Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Andrzej Frycz Modrzewski Kraków University, Kraków, Poland, Scientia Research Institute
- Responsible party
- Principal investigator, Adam Janas, American Heart of Poland
- Investigators
- Adam Janas, MD, PhD, Principal investigator, American Heart of Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918209
- Sponsor's protocol ID
- AHOP-PATRON HF/2024/05
- Other IDs
- 2024/ABM/01/00046
- Acronym
- PATRON-HF
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, Froelicher VF, Mark DB, McCallister BD, Mooss AN, O'Reilly MG, Winters WL Jr, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Russell RO, Smith SC Jr; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). ACC/AHA 2002 guideline update for exercise testing: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). Circulation. 2002 Oct 1;106(14):1883-92. doi: 10.1161/01.cir.0000034670.06526.15. No abstract available.
PubMed 12356646Swank AM, Horton J, Fleg JL, Fonarow GC, Keteyian S, Goldberg L, Wolfel G, Handberg EM, Bensimhon D, Illiou MC, Vest M, Ewald G, Blackburn G, Leifer E, Cooper L, Kraus WE; HF-ACTION Investigators. Modest increase in peak VO2 is related to better clinical outcomes in chronic heart failure patients: results from heart failure and a controlled trial to investigate outcomes of exercise training. Circ Heart Fail. 2012 Sep 1;5(5):579-85. doi: 10.1161/CIRCHEARTFAILURE.111.965186. Epub 2012 Jul 6.
PubMed 22773109Adamczak DM, Oduah MT, Kiebalo T, Nartowicz S, Beben M, Pochylski M, Cieplucha A, Gwizdala A, Lesiak M, Straburzynska-Migaj E. Heart Failure with Preserved Ejection Fraction-a Concise Review. Curr Cardiol Rep. 2020 Jul 9;22(9):82. doi: 10.1007/s11886-020-01349-3.
PubMed 32648130Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333.
PubMed 35083827
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Research Experiment to Compare the Standard Care Model to a Rehabilitation Strategy Based on Remotely Monitored, Regular Training Using a Bicycle Ergometer in Patients With Heart Failure With Preserved Ejection Fraction (PATRON-HF)
- ClinicalTrials.gov ID
- NCT07918209
- Acronym / sponsor ID
- PATRON-HF / AHOP-PATRON HF/2024/05
- Keywords
- Heart Failure with Preserved Ejection Fraction, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- American Heart of PolandUniversity, hospital or other
- Collaborators
- Andrzej Frycz Modrzewski Kraków University, Kraków, Poland, Scientia Research Institute
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 5 Nov 2026 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Other: TelerehabilitationTreatment 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). |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Presence of at least one of the following symptoms: dyspnea, orthopnea, paroxysmal nocturnal dyspnea, reduced exercise tolerance, fatigue, prolonged recovery time after exercise.
- Presence of at least one of the following findings on physical examination: elevated jugular venous pressure, hepatojugular reflux, audible third heart sound (S3), laterally displaced apical impulse.
- Presence of at least one of the following findings on transthoracic echocardiography: enlarged left atrium and/or left ventricle, E/e' ≥13, e' <9 cm/s.
- NT-proBNP >250 pg/mL or >600 pg/mL in patients with atrial fibrillation.
- Left ventricular ejection fraction (LVEF) ≥50%.
Key exclusion criteria (17 listed)
- History of myocardial infarction, stroke, transient ischemic attack, or another major cardiovascular event within the previous 60 days.
- Microvascular angina, defined as exertional anginal chest pain in the absence of stenosis in the epicardial coronary arteries.
- Left ventricular ejection fraction (LVEF) <50%.
- Diagnosed cardiomyopathy, including infiltrative, storage, hypertrophic, or cardiomyopathy caused by a known reversible etiology.
- Constrictive pericarditis.
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 |
|---|---|---|
| TelerehabilitationA 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. | Other | Telerehabilitation |
Primary outcome
Efficacy
Time frame: through study completion, an average of four months
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.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: through study completion, an average of four months
Assessment of the safety of remote rehabilitation in patients with heart failure with preserved ejection fraction (HFpEF).
4 secondary outcomes
Excercise capacity
Time frame: through study completion, an average of four months
NT-proBNP
Time frame: through study completion, an average of four months
Quality of life (Kansas City Cardiomyopathy Questionnaire)
Time frame: through study completion, an average of four months
Quality of life (EuroQol-5D
Time frame: through study completion, an average of four months
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 5 Nov 2026.
- Background: PubMed 12356646Gibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, Froelicher VF, Mark DB, McCallister BD, Mooss AN, O'Reilly MG, Winters WL Jr, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Russell RO, Smith SC Jr; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). ACC/AHA 2002 guideline update for exercise testing: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). Circulation. 2002 Oct 1;106(14):1883-92. doi: 10.1161/01.cir.0000034670.06526.15. No abstract available.
- Background: PubMed 22773109Swank AM, Horton J, Fleg JL, Fonarow GC, Keteyian S, Goldberg L, Wolfel G, Handberg EM, Bensimhon D, Illiou MC, Vest M, Ewald G, Blackburn G, Leifer E, Cooper L, Kraus WE; HF-ACTION Investigators. Modest increase in peak VO2 is related to better clinical outcomes in chronic heart failure patients: results from heart failure and a controlled trial to investigate outcomes of exercise training. Circ Heart Fail. 2012 Sep 1;5(5):579-85. doi: 10.1161/CIRCHEARTFAILURE.111.965186. Epub 2012 Jul 6.
- Background: PubMed 32648130Adamczak DM, Oduah MT, Kiebalo T, Nartowicz S, Beben M, Pochylski M, Cieplucha A, Gwizdala A, Lesiak M, Straburzynska-Migaj E. Heart Failure with Preserved Ejection Fraction-a Concise Review. Curr Cardiol Rep. 2020 Jul 9;22(9):82. doi: 10.1007/s11886-020-01349-3.
- Background: PubMed 35083827Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333.
- Individual participant dataSharing planned: Undecided
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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.
Adam Janas, MD, PhD principal investigator
American Heart of Poland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Heart Failure With Preserved Ejection Fraction, run by American Heart of Poland at 3 sites in Poland.
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 8 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. 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?
Contact Natalia Pydyn, PhD (+48 667 132 233, natalia.pydyn@ahop.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: through study completion, an average of four months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07918209, which also lists 4 linked publications.
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 5 Nov 2026.