Applying Telemedicine Technologies in a Novel Model of Organizing and Implementing Comprehensive Cardiac Rehabilitation in Heart Failure Patients - TELEREH-HF
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Heart Failure
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
- Enrollment
- 850
- Locations
- 5
- Primary Endpoint
- days alive and out of hospital
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
Dr Ewa Piotrowicz
MD, PhD
National Institute of Cardiology, Warsaw, Poland
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
days alive and out of hospital
Time Frame: up to 2 years