Rationale and design of a randomized controlled trial to assess the safety and efficacy of cardiac resynchronization therapy in patients with asymptomatic left ventricular dysfunction with previous symptoms or mild heart failure--the REsynchronization reV

Abstract:

BACKGROUND:Cardiac resynchronization therapy (CRT) improves symptoms, reduces heart failure (HF)-related hospitalizations, and reverses left ventricular remodeling in some patients with moderate to severe HF and ventricular dyssynchrony defined by a prolonged QRS duration. The effects of CRT on HF outcomes in patients with asymptomatic left ventricular dysfunction (ALVD) or mild HF remain to be determined. METHODS:The REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) study is a prospective, multicenter, randomized, double-blind, parallel, controlled clinical trial designed to establish whether CRT combined with optimal medical treatment can attenuate HF disease progression compared with optimal medical treatment alone in patients with ALVD +/- New York Heart Association class I American College of Cardiology/American Heart Association stage C or New York Heart Association class II HF, QRS duration > or =120 milliseconds, left ventricular ejection fraction < or =0.40, and left ventricular end-diastolic diameter > or =55 mm. The primary end point is the HF clinical composite response and left ventricular end-systolic volume index is the first-order secondary end point. Approximately 500 patients from 100 centers in the United States, Canada, and Europe will be randomized to CRT versus no CRT. The follow-up is 5 years in total with the primary and first secondary end points reported at 12 months. Enrollment began in September 2004 and is expected to be completed in 2006. CONCLUSION:REVERSE will assess the safety and efficacy of CRT in patients with ALVD or mild HF and electrocardiographic evidence of ventricular dyssynchrony.

journal_name

Am Heart J

journal_title

American heart journal

authors

Linde C,Gold M,Abraham WT,Daubert JC,REVERSE Study Group.

doi

10.1016/j.ahj.2005.03.002

subject

Has Abstract

pub_date

2006-02-01 00:00:00

pages

288-94

issue

2

eissn

0002-8703

issn

1097-6744

pii

S0002-8703(05)00222-X

journal_volume

151

pub_type

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