Clinical trial NCT02523560: Applying Telemedicine in a Model of Implementing Cardiac Rehabilitation in Heart Failure Patients
Official title: Applying Telemedicine Technologies in a Novel Model of Organizing and Implementing Comprehensive Cardiac Rehabilitation in Heart Failure Patients - TELEREH-HF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Telerehabilitation
Home Monitoring
Heart Failure
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
Collaborators: name: National Center for Research and Development, Poland
First posted: 2015-08-14
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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
* 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.

Primary outcomes:
measure: days alive and out of hospital
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Gdański Uniwersytet Medyczny
city: Warsaw
country: Poland
facility: Warsaw Medical University; Department of Cardiology
city: Warsaw
country: Poland
facility: Institute of Cardiology
city: Zabrze
country: Poland
facility: Slaskie Centrum Chorób Serca
city: Łódź
country: Poland
facility: Klinika Chorób Wewnętrznych i Rehabilitacji Kardiologicznej
Study officials:
affiliation: Institute of Cardiology, Telecardiology Center, Warsaw, Poland
name: Ewa Piotrowicz, MD
role: STUDY_DIRECTOR
affiliation: Warsaw Medical University, Department of Cardiology, Poland
name: Grzegorz Opolski, Prof
role: STUDY_CHAIR
References:
citation: Glowczynska R, Piotrowicz E, Szalewska D, Piotrowicz R, Kowalik I, Pencina MJ, Zareba W, Banach M, Orzechowski P, Pluta S, Irzmanski R, Kalarus Z, Opolski G. Effects of hybrid comprehensive telerehabilitation on cardiopulmonary capacity in heart failure patients depending on diabetes mellitus: subanalysis of the TELEREH-HF randomized clinical trial. Cardiovasc Diabetol. 2021 May 13;20(1):106. doi: 10.1186/s12933-021-01292-9.
citation: Piotrowicz E, Pencina MJ, Opolski G, Zareba W, Banach M, Kowalik I, Orzechowski P, Szalewska D, Pluta S, Glowczynska R, Irzmanski R, Oreziak A, Kalarus Z, Lewicka E, Cacko A, Mierzynska A, Piotrowicz R. Effects of a 9-Week Hybrid Comprehensive Telerehabilitation Program on Long-term Outcomes in Patients With Heart Failure: The Telerehabilitation in Heart Failure Patients (TELEREH-HF) Randomized Clinical Trial. JAMA Cardiol. 2020 Mar 1;5(3):300-308. doi: 10.1001/jamacardio.2019.5006.
citation: Piotrowicz E, Piotrowicz R, Opolski G, Pencina M, Banach M, Zareba W. Hybrid comprehensive telerehabilitation in heart failure patients (TELEREH-HF): A randomized, multicenter, prospective, open-label, parallel group controlled trial-Study design and description of the intervention. Am Heart J. 2019 Nov;217:148-158. doi: 10.1016/j.ahj.2019.08.015. Epub 2019 Aug 22.