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

Chronic Heart Failure Clinical Trial

— TELEREH-HF  

Official title:

Applying Telemedicine Technologies in a Novel Model of Organizing and Implementing Comprehensive Cardiac Rehabilitation in Heart Failure Patients - TELEREH-HF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523560
• Other study ID #: STRATEGME1/233547/13/NCBR/2015
• Status: Completed
• Phase: N/A
• First received: August 3, 2015
• Last updated: March 9, 2018
• Start date: June 2015
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Other:
• home-based telerehabilitation
Patients qualified to the study group will undergo, at five medical units a 9-week program of early hybrid, comprehensive cardiac telerehabilitation.

Locations

Country	Name	City	State
Poland	Gdanski Uniwersytet Medyczny	Gdansk
Poland	Klinika Chorób Wewnetrznych i Rehabilitacji Kardiologicznej	Lódz
Poland	Institute of Cardiology	Warsaw
Poland	Warsaw Medical University; Department of Cardiology	Warsaw
Poland	Slaskie Centrum Chorób Serca	Zabrze

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland	Poland: National Centre for Research and Development

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	days alive and out of hospital		up to 2 years