Remote rehabilitation for HFpEF patients using telerehabilitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a telerehabilitation approach delivered at home for adults with HFpEF. Participants may perform exercise on a bicycle ergometer while connected to ECG monitoring, enabling remote supervision. The goal is to determine safety and potential improvements in exercise tolerance and symptoms. Background shows HFpEF has limited treatment options and high healthcare burden, making accessible rehab promising. The trial focuses on translating cardiac rehabilitation into a home setting to overcome cost and logistical barriers.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Principal investigator: Adam Janas, MD, PhD — American Heart of Poland
• Study coordinator: Natalia Pydyn, PhD
• Email: natalia.pydyn@ahop.pl
• Phone: +48 667 132 233

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• EDG-15400 in adults with HFpEF: a phase 2 study

  This phase 2 study tests different doses of EDG-15400 against placebo in adults with HFpEF to see if it is safe and tolerable.

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• Incretin therapy with tirzepatide for obesity-related HFpEF

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  Recruiting Phase 4 Columbia University · New York, New York · NCT07554638

• Boosted exercise with group coaching for HFpEF

  This trial tests a blended, guided exercise program with group coaching and remote monitoring to see if it helps older adults with HFpEF improve activity and health at a lower cost.

  Recruiting Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT07413198

• Exercise cardiac MRI for heart failure with preserved ejection fraction

  This study will try low-field exercise cardiac MRI to see if it can diagnose, describe, and predict risk in people with HFpEF compared with those who have non-cardiac breathlessness and healthy volunteers.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07401771

• HRS-1893 for heart failure with preserved ejection fraction

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  Recruiting Phase 2 Shandong Suncadia Medicine Co., Ltd. · Shanghai, Shanghai Municipality · NCT07269717

• Pulmonary Artery Denervation for a specific type of heart and lung pressure problem

  This study tests whether the Enhancor System can safely and effectively help patients with combined pre- and post-capillary pulmonary hypertension due to left heart disease when added to standard therapy.

  Recruiting at 18 sites Pulnovo Medical, Inc. · Tucson, Arizona and 18 other locations · NCT07214376

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.