NCT07918209Toboroz
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
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)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 5.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 110 (tervezett)
- Első benyújtás
- 2026. okt. 6.
- Kezdés
- 2025. szept. 30.
- Elsődleges befejezés
- 2029. nov. 30.
- Fő szponzor
- American Heart of Poland
- Betegségek
- Szívelégtelenség
- NCT-szám
- NCT07918209
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 110
- 2025. szept. 30. és az elsődleges befejezés (2029. nov. 30.) között
- 3 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- History of myocardial infarction, stroke, transient ischemic attack, or another major cardiovascular event within the previous 60 days.
Más betegség
- Microvascular angina, defined as exertional anginal chest pain in the absence of stenosis in the epicardial coronary arteries.
- Atrial fibrillation or atrial flutter with a heart rate >110 bpm at the first visit.
- Acute decompensated heart failure.
- Chronic pulmonary disease requiring home oxygen therapy and/or oral corticosteroid therapy.
- Pulmonary hypertension.
- 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.
Laborértékek
- Left ventricular ejection fraction (LVEF) <50%.
- 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.
Egyéb
- Diagnosed cardiomyopathy, including infiltrative, storage, hypertrophic, or cardiomyopathy caused by a known reversible etiology.
- Constrictive pericarditis.
- Blood pressure >180/110 mmHg.
- In the investigator's opinion, the patient is unable to participate in the clinical trial.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 40 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (3)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów | Chrzanów | Lengyelország | Toboroz |
| Telcor Medical Center Scanmed | Katowice | Lengyelország | Toboroz |
| Polish-American Heart Clinics X Department of Invasive Cardiology, Electrophysiology and Electrostimulation in Tychy | Tychy | Lengyelország | Toboroz |
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