Resynchronisation/defibrillation for Ambulatory heart Failure Trial
| ISRCTN | ISRCTN16587532 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16587532 |
| ClinicalTrials.gov number | NCT00251251 |
| Secondary identifying numbers | UCT-63208 |
- Submission date
- 18/11/2005
- Registration date
- 18/11/2005
- Last edited
- 03/09/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anthony Sze-Leung Tang
Scientific
Scientific
University of Ottawa Heart Institute
H243, 40 Ruskin Street
Ottawa
K1Y 4W7
Canada
| Phone | +1 613 761 5442 |
|---|---|
| atang@ottawaheart.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study acronym | RAFT |
| Study objectives | 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(s) | Human Research Ethics Board, University of Ottawa Heart Institute, Ottawa Ontario approved on the 27/11/2002 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2003 |
| Completion date | 31/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1500 (1800 as of 25/06/2007) |
| Key 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. |
| Key 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) |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 31/08/2010 |
Locations
Countries of recruitment
- Australia
- Belgium
- Canada
- Germany
- Netherlands
- Türkiye
Study participating centre
University of Ottawa Heart Institute
Ottawa
K1Y 4W7
Canada
K1Y 4W7
Canada
Sponsor information
University of Ottawa Heart Institute (Canada)
Research organisation
Research organisation
40 Ruskin Street
Ottawa
K1Y 4W7
Canada
| Website | http://www.ottawaheart.ca/UOHI/Welcome.do |
|---|---|
"ROR" |
https://ror.org/03c4mmv16 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: UCT-63208)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/01/2009 | Yes | No | |
| Results article | results | 01/11/2013 | Yes | No |
