The RAFT study addresses the added value of resynchronization therapy (CRT) in heart failure patients with an ICD indication and optimal pharmacological treatment. Will this result in lower mortality and less hospitalization? Results of the study…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is a composite of total mortality and heart failure
hospitalization.
Secondary outcome
Secondary outcome measures include total mortality, cardiovascular mortality,
sudden arrhythmic death, hospitalization, health related quality of life, and
health economics. Other outcome measures: 6 minute hall walk distance, NYHA
Class changes, development of new atrial fibrillation, and non-fatal
ventricular tachycardia.
Background summary
Cardiac Resynchronization Therapy (CRT) is proven to be effective in patients
with advanced and severely debilitating heart failure (NYHA class III and IV).
The RAFT trial examines the added value of CRT to ICD and medical therapy in
patients with less advanced heart failure (NYHA class II).
Study objective
The RAFT study addresses the added value of resynchronization therapy (CRT) in
heart failure patients with an ICD indication and optimal pharmacological
treatment. Will this result in lower mortality and less hospitalization?
Results of the study may improve the treatment of these heart failure patients
(NYHA class II).
Study design
RAFT is a multi-center, prospective, double-blinded, randomized, controlled
trial. A total of 1800 heart failure patients with an implantable cardioverter
Defibrillator (ICD) indication will be included in 21 centers. Patients will be
randomly assigned (1:1 ratio) to one of two treatment groups: 1) ICD with CRT
(experimental group) and 2) ICD without CRT (control group). Both groups will
receive optimal pharmacological treatment.
Patients will be followed until the last enrolled patient completes the 18
month follow-up visit. Patients are followed during hospital follow-up visits
at 1, 6 and 12 months and, thereafter, every 6 months by blinded study
personnel who perform a heart failure assessment, and by unblinded study
personnel who perform the device follow-up. Additionally, in between hospital
visits, a blinded heart failure assessment and check for hospitalizations is
performed over the phone (3, 9 and 15 months post implant).
Intervention
ICD without CRT (control group) versus ICD plus CRT (experimental group). Both
groups receive optimal pharmacological treatment.
Study burden and risks
Burden/risk: Patients in the experimental group (ICD with CRT) will receive an
extra lead for stimulation of the left ventricle. This procedure involves
standard risks (p.3 patient information).
Benefit: Participating patients will be under more extensive medical
surveillance. The study may result in an improved treatment for patients with
less advanced heart failure.
Postbus 2542
6401 DA Heerlen
Nederland
Postbus 2542
6401 DA Heerlen
Nederland
Listed location countries
Age
Inclusion criteria
(Protocol p.10)
• NYHA Class II
• LV EF <= 30%
• Intrinsic QRS Complex Width >= 120 ms OR Paced QRS measurement >= 200 ms
• ICD indication for primary or secondary prevention (single or dual chamber system)
• Optimal heart failure pharmacological therapy
• Normal Sinus Rhythm OR
- Chronic persistent Atrial Tachyarrhythmia with resting Ventricular Heart Rate <= 60 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 Atrio-Ventricular Junction Ablation
Exclusion criteria
(Protocol p.10-11)
• Intra-venous 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)
• Patients with an acute coronary syndrome including MI1 can be included if the patient has had a previous MI with LV dysfunction (LVEF <= 30% )
• 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 satisfies all other inclusion/exclusion criteria)
• Coronary revascularization (CABG3 or PCI4) < 1 month if previously determined LVEF > 30%
Patients with a more recent revascularization can be included if a previous determined LVEF was <= 30%
• Patients included in other clinical trial that will affect the objectives of this study
• History of noncompliance of medical therapy
• Unable or unwilling to provide informed consent
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00251251 |
| CCMO | NL19769.075.07 |