RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Telerehabilitation for Heart Failure With Preserved Ejection Fraction

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.

Official registry: https://clinicaltrials.gov/study/NCT07918209 · American Heart of Poland · enrollment listed as 110

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Telerehabilitation. The registry lists allocation as randomized. 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.

They plan to enroll about 110 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

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)

Interventions: Telerehabilitation

Primary outcome (registry wording): Efficacy

Who it is for (from inclusion criteria)

Ages 40 Years to any
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%
Ability to perform exercise on a bicycle ergometer with ECG monitoring
No contraindications to coronary angiography

Who the registry excludes

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
Blood pressure \>180/110 mmHg

Public study contact (from the registry)

Natalia Pydyn, PhD

+48 667 132 233

natalia.pydyn@ahop.pl

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

3 listed

Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów — Chrzanów, Poland (recruiting)
Telcor Medical Center Scanmed — Katowice, Poland (recruiting)
Polish-American Heart Clinics X Department of Invasive Cardiology, Electrophysiology and Electrostimulation in Tychy — Tychy, Poland (recruiting)

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FAQ about this NCT record

Is NCT07918209 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07918209?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07918209?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary