Applying Telemedicine in a Model of Implementing Cardiac Rehabilitation in Heart Failure Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02523560
• Date of registration: 03/08/2015
• Prospective Registration: No
• Primary sponsor: Institute of Cardiology, Warsaw, Poland
• Public title: Applying Telemedicine in a Model of Implementing Cardiac Rehabilitation in Heart Failure Patients TELEREH-HF
• Scientific title: Applying Telemedicine Technologies in a Novel Model of Organizing and Implementing Comprehensive Cardiac Rehabilitation in Heart Failure Patients - TELEREH-HF
• Date of first enrolment: June 2015
• Target sample size: 850
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02523560
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Poland

Contacts

• Name: Ewa Piotrowicz, MD
• Affiliation: Institute of Cardiology, Telecardiology Center, Warsaw, Poland

• Name: Grzegorz Opolski, Prof
• Affiliation: Warsaw Medical University, Department of Cardiology, Poland

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Heart Failure

Intervention(s)

Other: home-based telerehabilitation

Primary Outcome(s)

days alive and out of hospital [Time Frame: up to 2 years]

Secondary ID(s)

STRATEGME1/233547/13/NCBR/2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Center for Research and Development, Poland