Resynchronization/Defibrillation for Ambulatory Heart Failure Trial (RAFT)

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Medtronic
Information provided by (Responsible Party):
Anthony Tang, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT00251251
First received: November 8, 2005
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

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 Intervention
Heart Failure, Congestive
Device: Optimal Medical Therapy plus ICD
Device: Optimal Medical Therapy plus CRT/ICD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Resynchronization/Defibrillation for Ambulatory Heart Failure Trial

Resource links provided by NLM:


Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • Primary outcome is a composite of all cause total mortality and hospitalization for CHF [ Time Frame: Study end ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total mortality [ Time Frame: Study end ] [ Designated as safety issue: No ]
  • Cardiovascular mortality [ Time Frame: Study end ] [ Designated as safety issue: No ]
  • Sudden arrhythmic death [ Time Frame: Study end ] [ Designated as safety issue: No ]
  • Progressive HF death [ Time Frame: Study end ] [ Designated as safety issue: No ]
  • All cause hospitalization rate [ Time Frame: Study end ] [ Designated as safety issue: No ]
  • CHF hospitalization rate [ Time Frame: Study end ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: Study end ] [ Designated as safety issue: No ]
  • Cost economics [ Time Frame: Study end ] [ Designated as safety issue: No ]

Enrollment: 1798
Study Start Date: April 2003
Study Completion Date: May 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Optimal Medical therapy plus ICD Device: Optimal Medical Therapy plus ICD
ICD vs CRT/ICD
Active Comparator: 2. Optimal Medical Therapy plus CRT/ICD Device: Optimal Medical Therapy plus CRT/ICD
ICD vs CRT/ICD

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251251

  Show 33 Study Locations
Sponsors and Collaborators
University of Ottawa Heart Institute
Canadian Institutes of Health Research (CIHR)
Medtronic
Investigators
Principal Investigator: Anthony Tang, MD University of Ottawa Heart Institute
Principal Investigator: George Wells, PhD University of Ottawa Heart Institute
  More Information

No publications provided by University of Ottawa Heart Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Anthony Tang, Principal Investigator, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT00251251     History of Changes
Other Study ID Numbers: FRN 63208, FRN 63208
Study First Received: November 8, 2005
Last Updated: June 15, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Ottawa Heart Institute:
Congestive heart failure
Multicentre randomized controlled trial
Defibrillator
Cardiac resynchronization
Sudden death/mortality
Hospitalization
ICD indication
NYHA Class II
LVEF </equal to 30%
QRS >/equal to 120 ms

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 10, 2014