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

Not Applicable

Completed

• Conditions: Heart Failure, Systolic
• Interventions: Procedure: cardiac resynchronization therapy

• Registration Number: NCT01577446
• Lead Sponsor: Ospedale Santa Maria di Loreto Mare

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 Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-12
• Study First Posted: 2012-04-13
• Primary Completion: 2012-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-15
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• NHYA class II-III heart failure
• ischemic cardiomyopathy
• ejection fraction of 35% or less
• QRS interval of 120ms or less
• evidence of mechanical dyssynchrony as measured on echocardiography

Exclusion Criteria

• conventional indication for cardiac pacing
• persistent atrial fibrillation
• life expectancy lower than 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRT	cardiac resynchronization therapy	The CRT group undergoes implantation of a CRT defibrillator

Primary Outcome Measures

Name	Time	Method
heart failure clinical composite score	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.

Secondary Outcome Measures

Name	Time	Method
time to the first heart failure hospitalization or death	up to 30 months	Kaplan-Meier analysis is used to analyze time to death or first heart failure hospitalization

Trial Locations

Locations (1)

Ospedale Santa Maria di Loreto Mare; 🇮🇹 Naples, Italy