NCT07918209 Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
| NCT ID | NCT07918209 |
| Status | Recruiting |
| Phase | — |
| Sponsor | American Heart of Poland |
| Condition | Heart Failure With Preserved Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2029-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2025-09-30 with a primary completion date of 2029-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 1. Presence of at least one of the following symptoms: dyspnea, orthopnea, paroxysmal nocturnal dyspnea, reduced exercise tolerance, fatigue, prolonged recovery time after exercise. 2. 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. 3. 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. 4. NT-proBNP \>250 pg/mL or \>600 pg/mL in patients with atrial fibrillation. 5. Left ventricular ejection fraction (LVEF) ≥50%. 6. Age \>40 years. 7. Ability to perform exercise on a bicycle ergometer with ECG monitoring. 8. No contraindications to coronary angiography. Exclusion Criteria: 1. History of myocardial infarction, stroke, transient ischemic attack, or another major cardiovascular event within the previous 60 days. 2. Microvascular angina, defined as exertional anginal chest pain in the absence of stenosis in the epicardial coronary arteries. 3. Left ventricular ejection fraction (LVEF) \<50%. 4. Diagnosed cardiomyopathy, including infiltrative, storage, hypertrophic, or cardiomyopathy caused by a known reversible etiology. 5. Constrictive pericarditis. 6. Atrial fibrillation or atrial flutter with a heart rate \>110 bpm at the first visit. 7. Blood pressure \>180/110 mmHg. 8. Acute decompensated heart failure. 9. Chronic pulmonary disease requiring home oxygen therapy and/or oral corticosteroid therapy. 10. Pulmonary hypertension. 11. Liver transaminase levels \>3 times the upper limit of the local reference range. 12. Chronic kidney disease with eGFR \<20 mL/min/1.73 m². 13. Hemoglobin \<9 mg/dL. 14. Active malignancy or suspected malignancy. 15. Alcohol use disorder or illicit drug use. 16. Allergy to the adhesive or material used in the electrodes required for telemonitoring. 17. In the investigator's opinion, the patient is unable to participate in the clinical trial.
Contact & Investigator
Adam Janas, MD, PhD
PRINCIPAL INVESTIGATOR
American Heart of Poland
Frequently Asked Questions
Who can join the NCT07918209 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Heart Failure With Preserved Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07918209 currently recruiting?
Yes, NCT07918209 is actively recruiting participants. Contact the research team at natalia.pydyn@ahop.pl for enrollment information.
Where is the NCT07918209 trial being conducted?
This trial is being conducted at Chrzanów, Poland, Katowice, Poland, Tychy, Poland.
Who is sponsoring the NCT07918209 clinical trial?
NCT07918209 is sponsored by American Heart of Poland. The principal investigator is Adam Janas, MD, PhD at American Heart of Poland. The trial plans to enroll 110 participants.
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