NCT02523560

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

2.8 years

First QC Date

August 3, 2015

Last Update Submit

March 9, 2018

Conditions

Chronic Heart Failure

Keywords

TelerehabilitationHome MonitoringHeart Failure

Outcome Measures

Primary Outcomes (1)

  • days alive and out of hospital

    up to 2 years

Study Arms (2)

telerehabilitation group

EXPERIMENTAL

1 week hospital rehabilitation and 8 weeks home-based telerehabilitation and telemanagement (including HomeMonitoring)

Other: home-based telerehabilitation

control group

NO INTERVENTION

Patients qualified to the control group will undergo a 9-week procedure appropriate to their clinical condition/status standardized for a particular center (usual care).

Interventions

home-based telerehabilitationOTHER

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

telerehabilitation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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);
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Gdański Uniwersytet Medyczny

Gdansk, 80-210, Poland

Location

Klinika Chorób Wewnętrznych i Rehabilitacji Kardiologicznej

Lodz, 90-647, Poland

Location

Warsaw Medical University; Department of Cardiology

Warsaw, 02-097, Poland

Location

Institute of Cardiology

Warsaw, 04-628, Poland

Location

Slaskie Centrum Chorób Serca

Zabrze, 41-800, Poland

Location

Related Publications (5)

  • Mierzynska A, Jaworska I, Piotrowicz R, Kowalik I, Pencina M, Opolski G, Zareba W, Banach M, Orzechowski P, Glowczynska R, Szalewska D, Pluta S, Kalarus Z, Irzmanski R, Piotrowicz E. The Influence of Hybrid Comprehensive Telerehabilitation on Anxiety in Heart Failure Patients: The TELEREH-HF Randomized Clinical Trial. J Clin Psychol Med Settings. 2024 Jun;31(2):403-416. doi: 10.1007/s10880-023-09985-x. Epub 2023 Dec 18.

    PMID: 38108961DERIVED

  • Yang Z, Jia X, Li J, Mei Z, Yang L, Yan C, Han Y. Efficacy and Safety of Hybrid Comprehensive Telerehabilitation (HCTR) for Cardiac Rehabilitation in Patients with Cardiovascular Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Occup Ther Int. 2023 Aug 9;2023:5147805. doi: 10.1155/2023/5147805. eCollection 2023.

    PMID: 37593110DERIVED

  • 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.

    PMID: 33985509DERIVED

  • 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.

    PMID: 31734701DERIVED

  • 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.

    PMID: 31654944DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Ewa Piotrowicz, MD

    Institute of Cardiology, Telecardiology Center, Warsaw, Poland

    STUDY DIRECTOR

  • Grzegorz Opolski, Prof

    Warsaw Medical University, Department of Cardiology, Poland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 14, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 13, 2018

Record last verified: 2018-03

Locations

PL(5)