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

This study has been completed.
Information provided by (Responsible Party):
Carmine Muto, Ospedale Santa Maria di Loreto Mare Identifier:
First received: April 11, 2012
Last updated: October 15, 2016
Last verified: October 2016
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.

Condition Intervention
Heart Failure, Systolic
Procedure: cardiac resynchronization therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy

Resource links provided by NLM:

Further study details as provided by Ospedale Santa Maria di Loreto Mare:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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

Enrollment: 120
Study Start Date: January 2008
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CRT
The CRT group undergoes implantation of a CRT defibrillator
Procedure: cardiac resynchronization therapy
Implantation of a CRT defibrillator with a standard right atrial, right ventricular defibrillator and left ventricular leads
No Intervention: no-CRT
The no-CRT group receives a dual-chamber defibrillator


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01577446

Ospedale Santa Maria di Loreto Mare
Naples, Italy
Sponsors and Collaborators
Ospedale Santa Maria di Loreto Mare
Study Chair: Carmine Muto, MD Ospedale Santa Maria di Loreto Mare
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Carmine Muto, Electrophysiology and Pacing Unit Director, Ospedale Santa Maria di Loreto Mare Identifier: NCT01577446     History of Changes
Other Study ID Numbers: LM-002
Study First Received: April 11, 2012
Last Updated: October 15, 2016

Keywords provided by Ospedale Santa Maria di Loreto Mare:
heart failure
narrow QRS

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases processed this record on May 25, 2017