Applying Telemedicine in a Model of Implementing Cardiac Rehabilitation in Heart Failure Patients
- Conditions
- Chronic Heart Failure
- Registration Number
- NCT02523560
- Lead Sponsor
- National Institute of Cardiology, Warsaw, Poland
- Brief Summary
Applying modern technology of data collecting, monitoring, transmitting and analyzing in order to implement a novel (hybrid) model of comprehensive home-based cardiac rehabilitation in heart failure patients.
- Detailed Description
Heart failure (HF) epidemic is an aggressively developing phenomenon, stimulated by developing civilization and generating worrying economic and social effects. Early comprehensive cardiac rehabilitation (CCR) is an accepted method of preventing and treating adverse cardiac events, which allows for care cost reduction. In Poland, CCR availability is highly unsatisfactory (around 8%) and unacceptably varied (0.5-70%). With the existing organization and technical background, improving this situation seems impossible. Project objective: To apply telemedicine technologies to implement a novel model of home-based CCR in HF patients.
The program, performed in six centers, will comprise 850 HF patients (randomization 1:1), in NYHA class I-III, EF≤40%, clinically stable, after a hospitalization incident. The study group patients will undergo a 9-week rehabilitation program consisting of two stages: Stage I - preliminary (one week at stationary ward), Stage II - main (8 weeks of home-based telerehabilitation). The primary end-point (days alive and out of hospital) will be assessed during a 24-month follow-up in both groups. The project will enable early secondary prevention in the population of people with HF to be implemented. It will be achieved via:
* Novel concept - "From Hospital To Home"
* Novel technology - telemedicine
* Novel method of CCR implementation
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 850
- patients of either sex with any aetiology of left ventricular systolic HF [as defined in the European Society of Cardiology (ESC) guidelines]
- with a left ventricular ejection fraction (LVEF) ≤40% on echocardiography;
- in New York Heart Association (NYHA) class I, II or III;
- who are to have had a hospitalization incident, be stable clinically (a patient does not need intravenous medication or has not had therapy modified for at least 7 days);
- who has no contraindications to undergo cardiopulmonary exercise test and
- who are able to exercise using the new model of home-based telerehabilitation.
- NYHA class IV;
- unstable angina;
- unstable clinical status
- a history of acute coronary syndrome within the last forty days in patients with LVEF ≤35%; percutaneous angioplasty (PCI) within the last 2 weeks, coronary artery bypass grafting within the last 3 months, or initiation of cardiac resynchronization therapy (CRT-P, CRT-D) and/or implantable cardioverter-defibrillator (ICD) or pacemaker within the last six weeks;
- lack of ICD, CRT-P or CRT-D therapy despite the indications for implantation according to ESC guidelines;
- intracardiac thrombus
- rest heart rate (HR) >90/min,
- tachypnoea >20 breaths per minute
- symptomatic and/or exercise-induced cardiac arrhythmia or conduction disturbances;
- acute myocarditis and/or pericarditis
- valvular or congenital heart disease requiring surgical treatment;
- hypertrophic cardiomyopathy;
- severe pulmonary disease;
- uncontrolled hypertension;
- anemia (haemoglobin <11.0 g/dL);
- physical disability related to severe musculoskeletal or neurological problems;
- recent embolism;
- thrombophlebitis;
- acute or chronic inflammatory disease;
- acute or chronic decompensated non-cardiac diseases (thyreotoxicosis, uncontrolled diabetes)
- active malignant neoplastic diseases with survival prognosis below 2 - 5 years;
- orthotropic heart transplant in anamnesis;
- aortic aneurysm;
- severe psychiatric disorder; and
- patient's refusal to participate.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method days alive and out of hospital up to 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Gdański Uniwersytet Medyczny
🇵🇱Gdańsk, Poland
Warsaw Medical University; Department of Cardiology
🇵🇱Warsaw, Poland
Institute of Cardiology
🇵🇱Warsaw, Poland
Slaskie Centrum Chorób Serca
🇵🇱Zabrze, Poland
Klinika Chorób Wewnętrznych i Rehabilitacji Kardiologicznej
🇵🇱Łódź, Poland
Gdański Uniwersytet Medyczny🇵🇱Gdańsk, Poland