Document Detail

Effects of cardiac resynchronization on disease progression in patients with left ventricular systolic dysfunction, an indication for an implantable cardioverter-defibrillator, and mildly symptomatic chronic heart failure.
MedLine Citation:
PMID:  15505095     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The effects of cardiac resynchronization therapy (CRT) in patients with mildly symptomatic heart failure have not been fully elucidated. METHODS AND RESULTS: The Multicenter InSync ICD Randomized Clinical Evaluation II (MIRACLE ICD II) was a randomized, double-blind, parallel-controlled clinical trial of CRT in NYHA class II heart failure patients on optimal medical therapy with a left ventricular (LV) ejection fraction < or =35%, a QRS > or =130 ms, and a class I indication for an ICD. One hundred eighty-six patients were randomized: 101 to the control group (ICD activated, CRT off) and 85 to the CRT group (ICD activated, CRT on). End points included peak VO2, VE/CO2, NYHA class, quality of life, 6-minute walk distance, LV volumes and ejection fraction, and composite clinical response. Compared with the control group at 6 months, no significant improvement was noted in peak VO2, yet there were significant improvements in ventricular remodeling indexes, specifically LV diastolic and systolic volumes (P=0.04 and P=0.01, respectively), and LV ejection fraction (P=0.02). CRT patients showed statistically significant improvement in VE/CO2 (P=0.01), NYHA class (P=0.05), and clinical composite response (P=0.01). No significant differences were noted in 6-minute walk distance or quality of life scores. CONCLUSIONS: In patients with mild heart failure symptoms on optimal medical therapy with a wide QRS complex and an ICD indication, CRT did not alter exercise capacity but did result in significant improvement in cardiac structure and function and composite clinical response over 6 months.
William T Abraham; James B Young; Angel R León; Stuart Adler; Alan J Bank; Shelley A Hall; Randy Lieberman; L Bing Liem; John B O'Connell; John S Schroeder; Kevin R Wheelan;
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2004-10-25
Journal Detail:
Title:  Circulation     Volume:  110     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2004 Nov 
Date Detail:
Created Date:  2004-11-02     Completed Date:  2005-09-30     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2864-8     Citation Subset:  AIM; IM    
Ohio State University Heart Center, Division of Cardiovascular Medicine, 473 W 12th Ave, Room 110P DHLRI, Columbus, OH 43210-1252.
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MeSH Terms
Cardiovascular Agents / therapeutic use
Defibrillators, Implantable
Disease Progression
Double-Blind Method
Electric Countershock*
Exercise Test
Exercise Tolerance
Heart Conduction System / physiopathology*
Heart Failure / drug therapy,  surgery,  therapy*
Middle Aged
Postoperative Complications / epidemiology
Survival Rate
Tachycardia, Ventricular / epidemiology,  prevention & control
Treatment Outcome
Ventricular Dysfunction, Left / drug therapy,  surgery,  therapy*
Ventricular Fibrillation / epidemiology,  prevention & control
Ventricular Remodeling
Reg. No./Substance:
0/Cardiovascular Agents

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