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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19102034
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23995437
Publication citations
-
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.
-
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.