Clinical Trial: Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy (NARROW CRT)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy

Brief Summary: Current recommendations require a QRS duration of ≥120ms as a condition for prescribing cardiac resynchronization therapy (CRT). This study was designed to test the hypothesis that patients with heart failure of ischemic origin, current indications for defibrillator implantation and QRS <120ms may benefit from CRT in the presence of marked mechanical dyssynchrony.

Detailed Summary:
Sponsor: Ospedale Santa Maria di Loreto Mare

Current Primary Outcome: heart failure clinical composite score [ Time Frame: 12 months ]

Patients are classified according to a score, which assigns subjects to one of three response groups — improved, worsened, or unchanged. Patients are judged to be worsened if they died or were hospitalized because of worsening heart failure (at any time during the 12 months), or demonstrated worsening in NYHA functional class at their 12-month visit. Patients are judged to be improved if they had not worsened and had demonstrated improvement in NYHA functional class at 12 months. Patients who are not worsened or improved are classified as unchanged.


Original Primary Outcome: Same as current

Current Secondary Outcome: time to the first heart failure hospitalization or death [ Time Frame: up to 30 months ]

Kaplan-Meier analysis is used to analyze time to death or first heart failure hospitalization


Original Secondary Outcome: Same as current

Information By: Ospedale Santa Maria di Loreto Mare

Dates:
Date Received: April 11, 2012
Date Started: January 2008
Date Completion:
Last Updated: October 15, 2016
Last Verified: October 2016