Condition category
Circulatory System
Date applied
18/11/2005
Date assigned
18/11/2005
Last edited
03/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anthony Sze-Leung Tang

ORCID ID

Contact details

University of Ottawa Heart Institute
H243
40 Ruskin Street
Ottawa
K1Y 4W7
Canada
+1 613 761 5442
atang@ottawaheart.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00251251

Protocol/serial number

UCT-63208

Study information

Scientific title

The addition of cardiac resynchronisation therapy to implantable cardioverter-defibrillator and optimal medical therapy to patients with mild to moderate congestive heart failure symptoms: a randomised controlled trial

Acronym

RAFT

Study hypothesis

In patients with left ventricular (LV) dysfunction (ejection fraction [EF] less than or equal to 30%), QRS duration greater than or equal to 120 ms, and mild to moderate congestive heart failure (CHF) symptoms, the addition of cardiac resynchronisation therapy (CRT) to implantable cardioverter-defibrillator (ICD) and optimal medical therapy reduces the combined end point of all-cause mortality and CHF hospitalisation.

As of 06/03/2009 this record was updated; all amendments can be found in the relevant field under the above update date. Please note that the countries of recruitment were extended at this time to include Germany, Australia, Belgium, Netherlands and Turkey. At this time the anticipated end date was also amended; the initial end date at the time of registration was 30/04/2008.

Ethics approval

Human Research Ethics Board, University of Ottawa Heart Institute, Ottawa Ontario approved on the 27/11/2002

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Congestive heart failure

Intervention

ICD plus Optimal Medical Therapy (control) or CRT/ICD plus Optimal Medical Therapy (experimental); permanent implanted device-length of study

Trial details received 12 Sept 2005

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Total mortality and hospitalisation for CHF. Total mortality includes any death. Hospitalisation for CHF is defined as an admission to hospital with a diagnosis of worsening CHF for greater than 24 hours.

Secondary outcome measures

1. Cardiovascular mortality in comparison to total mortality same as above
2. Sudden arrhythmic death in comparison to total mortality as above
3. Progressive CHF death in comparison to total mortality same as above
4. All causes of hospitalisation rate
5. CHF hospitalisation rate throughout the length of the trial
6. Health related quality of life and cost economics using the MLWHF questionnaire and EQ5D questionnaire

Overall trial start date

01/04/2003

Overall trial end date

31/08/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Amended 06/03/2009:
Point 2 has been removed: 'Aged greater than or equal to 30, either sex'.

Initial information at the time of registration:
1. New York Heart Association (NYHA) class II
2. Aged greater than or equal to 30 years old, either sex
3. LVEF less than or equal to 30% by multiple gated acquisition (MUGA) scan or LVEF less than or equal to 30% and LV end diastolic dimension greater than 60 mm (by echocardiogram) within 6 months of randomisation
4. QRS duration greater than or equal to 120 ms
5. Optimal heart failure pharmacological therapy
6. ICD indication for primary or secondary prevention
7. Normal sinus rhythm OR chronic persistent atrial fibrillation with resting ventricular heart rate less than or equal to 60 bpm and ventricular rate less than or equal to 90 bpm during a 6-minute hall walk. This can be accomplished by pharmacological therapy or catheter AV Junction Ablation.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1500 (1800 as of 25/06/2007)

Participant exclusion criteria

1. In hospital patients who have acute cardiac or non-cardiac cause
2. Intra-venous inotropic agent in the last 4 days
3. Patients with a life expectancy of less than 1 year non-cardiac cause
4. Expected to under go cardiac transplantation within 1 year (status I)
5. Patients with an acute coronary syndrome including myocardial infarction (MI) can be included if the patient has had a previous MI with LV dysfunction (LVEF less than or equal to 30%)
6. Unable or unwilling to provide informed consent
7. History of noncompliance of medical therapy
8. Uncorrected or uncorrectable primary valvular disease
9. Restrictive, hypertrophic or reversible form of cardiomyopathy
10. Severe primary pulmonary disease such as cor pulmonale
11. Tricuspid prosthetic valve
12. Patients included in other clinical trial that will affect the objectives of this study
13. Coronary revascularisation (coronary artery bypass graft [CABG] or percutaneous coronary intervention [PCI]) less than 1 month if previously determined LVEF greater than 30%. Patients with a more recent revascularisation can be included if a previous determined LVEF was less than or equal to 30%
14. Patients with an existing ICD (patients with an existing pacemaker may be included if the patients satisfies all other inclusion/exclusion criteria)

Recruitment start date

01/04/2003

Recruitment end date

31/08/2010

Locations

Countries of recruitment

Australia, Belgium, Canada, Germany, Netherlands, Turkey

Trial participating centre

University of Ottawa Heart Institute
Ottawa
K1Y 4W7
Canada

Sponsor information

Organisation

University of Ottawa Heart Institute (Canada)

Sponsor details

40 Ruskin Street
Ottawa
K1Y 4W7
Canada

Sponsor type

Research organisation

Website

http://www.ottawaheart.ca/UOHI/Welcome.do

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: UCT-63208)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19102034
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23995437

Publication citations

  1. Protocol

    Tang AS, Wells GA, Arnold M, Connolly S, Hohnloser S, Nichol G, Rouleau J, Sheldon R, Talajic M, Resynchronization/defibrillation for ambulatory heart failure trial: rationale and trial design., Curr. Opin. Cardiol., 2009, 24, 1, 1-8.

  2. Results

    Birnie DH, Ha A, Higginson L, Sidhu K, Green M, Philippon F, Thibault B, Wells G, Tang A, Impact of QRS morphology and duration on outcomes after cardiac resynchronization therapy: Results from the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT)., Circ Heart Fail, 2013, 6, 6, 1190-1198, doi: 10.1161/CIRCHEARTFAILURE.113.000380.

Additional files

Editorial Notes