Clinical Trial: Protocol No. P-KARE-01

STUDY SYNOPSIS

Clinical Trial: Protocol No. P-KARE-01

REhabilitation, quality of Life, And eXercise tolerance in Internal Cardioverter-Defibrillator-patients

(RELAX-ICD Trial)

An international prospective randomised multicentre study,

proposed by the European Working Group on Cardiac Rehabilitation and Exercise Physiology

Principal Investigators/ Jean-Paul Schmid

Steering Committee: Dorothy Frizelle

Patrick Doherty

Luc Vanhees

Etienne Delacrétaz

Hannah McGee

Bob Lewin

Neil Oldridge

Hugo Saner

Coordinating Centre & Swiss Cardiovascular Centre Bern

ICD Tracing Core Lab Cardiovascular Prevention & Rehabilitation

University Hospital (Inselspital)

3010 Bern

Switzerland

EudraCT Nr. 2006-003593-10

ID Nr. NCT00346112

1. Study Synopsis

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Title

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REhabilitation, quality of Life, And eXercise tolerance in Internal Cardioverter-Defibrillator-patients (RELAX-ICD Trial)

Study design

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International prospective randomised multicentre trial

Centre eligibility

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-  Collaboration with a department of clinical electrophysiology with an implantation volume of minimum 15 ICD’s/year

-  Ability to include 10 ICD patients/year into the study
-  Structured, comprehensive cardiac rehabilitation programme which fulfills the quality criteria of the study protocol
-  Support from a psychologist and/or cardiac healthcare professional trained in counselling and delivering a cognitive behavioural intervention (including the attendance of a training meeting on the psychoeducational intervention delivered in the RELAX-ICD trial)
-  Possibility to perform a cardiopulmonary exercise test with respiratory gas analysis on treadmill or bicycle

Inclusion criteria

/ -  Men & women ³ age 18
-  First ICD implantation during the last 12 weeks

-  Signed informed consent

Exclusion criteria

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-  Angina pectoris CCS III & IV

-  NYHA functional class IV
-  Cognitive impairment (judgement by clinician)
-  Inability to participate in a regular rehabilitation programme
-  Poor knowledge of national language
-  Exercise limitations due to clinical conditions not related to heart disease
-  Known symptomatic exercise-induced tachyarrhythmias
-  Any major non-cardiac condition, that would adversely affect survival during the duration of the study
-  Patients unlikely to comply to the study and/or follow-up visits (incl. abuse of any substances)
-  Participation in a concurrent investigational research study

Intervention groups

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Patients are randomised into:

Group 1: Comprehensive cardiovascular rehabilitation programme
Group 2: Psychoeducational counselling only
Group 3: Usual care

Group 1

Exercise & psychoeducational counselling

/ Comprehensive cardiovascular rehabilitation programme
Exercise training in patients without history of heart failure:
Two official supervised trainings a week during a 3 months period, a third supervised training or with a record from home training. Exercise training includes supervised aerobic endurance ergometer training, callisthenics, walking, water gymnastics or cycling (depending on local programme habits)
Exercise training in patients with history of heart failure:
Same frequency of training sessions as in patients without history of heart failure, but training intensity adapted to heart failure (e.g. interval ergometer training)
Psychoeducational counselling:
Education and information, cognitive behavioural intervention, psychosocial support: 12 hours in total during 3 months programme

Group 2

Psychoeducational counselling only

/ Psychoeducational counselling:
Education and information, cognitive behavioural intervention, psychosocial support: 12 hours in total during 3 months

Group 3

Control group

/ Usual care:
From surgeon/electrophysiologist & general physician

Sample size

/ 318 patients (106 per group)

Randomisation period

/ April 2006 until April 2008

Primary outcome measure

/ -  Anxiety and depression scores (HADS)

Secondary outcome measures

/ -  Anxiety and depression scores in partners
-  Health related quality of life in patients (SF-36, MacNew) and partners (SF-36)
-  Exercise capacity (peak VO2)
-  Number of registered tachyarrhythmias, episodes of antitachycardia pacing and ICD-shocks
-  Number of rehospitalisations and deaths

Substudies

/ -  Arrhythmias caused by exercise: Luc Vanhees, Hein Heidbüchel, Patrick Doherty
-  Cognitive behavioural intervention: Dorothy Frizelle, Hannah McGee
-  Quality of partner relationship: Dorothy Frizelle, Hannah McGee
-  Course of quality of life in patients with repetitive ICD shocks (≥ 3 shocks within 3 months): Etienne Delacrétaz, Jean-Paul Schmid