Resynchronization/Defibrillation for Ambulatory Heart Failure Trial (RAFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251251
Recruitment Status : Completed
First Posted : November 9, 2005
Last Update Posted : June 18, 2012
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Anthony Tang, Ottawa Heart Institute Research Corporation

Brief Summary:
Congestive heart failure (CHF) is a common health problem that leads to frequent hospitalizations and an increased death rate. In spite of advances in drug therapy, it remains a significant public health problem. Recently, a new therapy has been developed for advanced heart failure patients with a ventricular conduction abnormality. This new therapy, called cardiac resynchronization (CRT), is a device which stimulates the atrium, the right ventricle, and the left ventricle providing synchronization of the contraction of the heart chambers. It is the addition of this therapy to an implantable cardioverter defibrillator (ICD) that will be evaluated in this study. This study will compare whether the implantation of this new therapy device, in combination with an implantable cardioverter defibrillator, will reduce total mortality and hospitalizations for CHF.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Device: Optimal Medical Therapy plus ICD Device: Optimal Medical Therapy plus CRT/ICD Not Applicable

Detailed Description:

Cardiovascular mortality is decreasing in most industrial countries, however mortality for congestive heart failure is increasing. The most important predictors of mortality in heart failure patients are depressed left ventricular function, severity of symptoms (NYHA class), and ventricular conduction abnormality manifested as wide QRS. Recent advances in pharmacological therapy including ACE inhibitors, beta-blocker and spironolactone have resulted in improvement of symptoms and reduction in mortality. Population epidemiological studies demonstrated that mortality and hospitalization rate for heart failure remains very high despite recent pharmacological therapeutic progress. Recent short-term clinical trials demonstrated that cardiac resynchronization therapy (CRT) is effective in improving symptoms of heart failure, functional capacity and quality of life in patients with moderate to severe heart failure and conduction abnormality optimally treated with drug therapy. However, the data for morbidity and mortality in mild to moderate heart failure is lacking.

The objective of this trial is to determine if the addition of CRT to optimal pharmacological therapy and ICD is effect in reducing mortality and morbidity in patients with poor LV function, wide QRS and mild to moderate heart failure symptoms.

This is a double-blinded randomized control trial. A total of 1800 patients with mild to moderate heart failure symptoms, LVEF ≤ 30%, and QRS ≥ 120 ms will be included in the study. Patients will be randomized to either "ICD plus Optimal Medical Therapy (control)" or "CRT/ICD plus Optimal Medical Therapy (experimental)" in a 1:1 randomization ratio. Patients in the control group will be implanted with a single or dual chamber ICD. Patients in the experimental group will receive a device with the capabilities of CRT and ICD. Optimal Medical Therapy will include ACE inhibitors and beta-blockers. Patients will be followed on a regular basis and will have clinical evaluation, quality of life assessment, and six minute walk tests performed. The primary outcome is a composite of total mortality and heart failure hospitalization. Secondary outcome measures will include total mortality, cardiovascular mortality, sudden arrhythmic death, health related quality of life and cost economics. Patient accruement is scheduled for 4.5 years and a minimum follow of 18 months.

DFT sub study:

Overview of sub-study Design Patients participating in the RAFT trial, at participating sites, will be randomized to have DFT testing or no testing at the time of device implant. Up to 450 patients will be eligible for enrollment at Canadian and European centres. The study will have two primary outcomes: a short-term safety outcome and a long-term efficacy outcome. The safety outcome will be a composite of all adverse events potentially related to DFT that occur within 30 days following ICD implant. The long-term efficacy outcome will be a composite of failed first appropriate clinical ICD shock and sudden death. This pilot study is intended primarily to confirm the anticipated rates of events and to demonstrate feasibility of enrollment, but will not have statistical power to determine if intra-operative DFT testing is associated with significant short-term risk. If complication rates are as high as predicted and enrollment is feasible, then a larger study would be justified to determine the impact of intra-operative DFT testing on long-term rates of failed appropriated ICD shocks and sudden death. Events rates determined in this pilot study would then be used to estimate the sample size of this larger study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1798 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Resynchronization/Defibrillation for Ambulatory Heart Failure Trial
Study Start Date : April 2003
Actual Primary Completion Date : September 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1. Optimal Medical therapy plus ICD Device: Optimal Medical Therapy plus ICD
Active Comparator: 2. Optimal Medical Therapy plus CRT/ICD Device: Optimal Medical Therapy plus CRT/ICD

Primary Outcome Measures :
  1. Primary outcome is a composite of all cause total mortality and hospitalization for CHF [ Time Frame: Study end ]

Secondary Outcome Measures :
  1. Total mortality [ Time Frame: Study end ]
  2. Cardiovascular mortality [ Time Frame: Study end ]
  3. Sudden arrhythmic death [ Time Frame: Study end ]
  4. Progressive HF death [ Time Frame: Study end ]
  5. All cause hospitalization rate [ Time Frame: Study end ]
  6. CHF hospitalization rate [ Time Frame: Study end ]
  7. Health related quality of life [ Time Frame: Study end ]
  8. Cost economics [ Time Frame: Study end ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • New York Heart Association (NYHA) Class II
  • Left ventricular ejection fraction (LVEF) less than or equal to 30% by multigated acquisition scan (MUGA)/catheterization OR LVEF less than or equal to 30% and LV end diastolic dimension ≥ 60 mm (by echocardiogram) within 6 months prior to randomization
  • Intrinsic QRS complex width ≥ 120 ms OR paced QRS measurement ≥ 200 ms
  • ICD indication for primary or secondary prevention
  • Optimal heart failure pharmacological therapy
  • Normal sinus rhythm; OR chronic persistent atrial tachyarrhythmia with resting ventricular heart rate ≤ 60 beats per minute (bpm) and 6 minute hall walk ventricular heart rate of ≤ 90 bpm; OR chronic persistent atrial tachyarrhythmia with resting ventricular heart rate > 60 bpm and 6 minute hall walk ventricular heart rate of > 90 bpm and booked for atrioventricular junction ablation.

Exclusion Criteria:

  • Intravenous inotropic agent in the last 4 days
  • Patients with a life expectancy of less than one year from non-cardiac cause
  • Expected to undergo cardiac transplantation within one year (status I)
  • In hospital patients who have acute cardiac or non-cardiac illness that requires intensive care
  • Uncorrected or uncorrectable primary valvular disease
  • Restrictive, hypertrophic, or reversible form of cardiomyopathy
  • Severe primary pulmonary disease such as cor pulmonale
  • Tricuspid prosthetic valve
  • Patients with an existing ICD (patients with an existing pacemaker may be included if the patients satisfy all other inclusion/exclusion criteria)
  • Coronary revascularization (coronary artery bypass graft surgery [CABG] or percutaneous coronary intervention [PCI]) < 1 month if previously determined LVEF > 30%. Patients with a more recent revascularization can be included if a previously determined LVEF was ≤ 30%.
  • Patients with an acute coronary syndrome including myocardial infarction (MI) can be included if the patients have had a previous MI with LV dysfunction (LVEF ≤ 30%).
  • Patients included in another clinical trial that will affect the objectives of this study
  • History of noncompliance to medical therapy
  • Unable or unwilling to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00251251

  Hide Study Locations
Royal Adelaide Hospital
Adelaide, Australia, 5000
Sir Charles Gairdner Hospital
Perth, Australia, 6009
University Ziekenhuis
Leuven, Belgium
Canada, Alberta
University of Calgary/Foothill Hospital
Calgary, Alberta, Canada, T2N 2T9
Alberta Heart Institute
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, Canada, V8R 4R2
Canada, New Brunswick
NB Heart Centre Research Initiative
St. John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Memorial Hospital
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Queen Elizabeth II
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada, L8L 2X2
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
St. Mary's Hospital
Kitchener, Ontario, Canada, N2M 1B2
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Southlake Regional Health Care
Newmarket, Ontario, Canada, L3Y 8C3
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4 W7
Sunnybrook Hospital
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
UHN Toronto General
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
CHUM Hopital Notre Dame
Montreal, Quebec, Canada, H2L 4M1
McGill University Health Centre
Montreal, Quebec, Canada, H3A 1A1
Hopital du Sacre Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Laval Hospital
Quebec City, Quebec, Canada, G1V 4G5
CHUS Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Skejby University Hospital
Aarhus, Denmark
Bad Berka, Germany
J.W. Goethe University
Frankfurt, Germany, 60590
University of Giessen
Giessen, Germany
Ludwigshafen, Germany
University of Mainz
Mainz, Germany
Isala Klinieken
Zwolle, Netherlands
Ege University
Izmir, Turkey
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Anthony Tang, MD Ottawa Heart Institute Research Corporation
Principal Investigator: George Wells, PhD Ottawa Heart Institute Research Corporation

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Anthony Tang, Principal Investigator, Ottawa Heart Institute Research Corporation Identifier: NCT00251251     History of Changes
Other Study ID Numbers: FRN 63208
FRN 63208
First Posted: November 9, 2005    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: June 2012

Keywords provided by Anthony Tang, Ottawa Heart Institute Research Corporation:
Congestive heart failure
Multicentre randomized controlled trial
Cardiac resynchronization
Sudden death/mortality
ICD indication
LVEF </equal to 30%
QRS >/equal to 120 ms

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases