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

NCT01577446 | Completed

• 1 other identifier: LM-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Systolic

Keywords

CRT; heart failure; narrow QRS; dyssynchrony

Outcome Measures

Primary Outcomes (1)

• heart failure clinical composite score

  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.

  12 months

Secondary Outcomes (1)

• time to the first heart failure hospitalization or death

  up to 30 months

Study Arms (2)

CRT

EXPERIMENTAL

The CRT group undergoes implantation of a CRT defibrillator

Procedure: cardiac resynchronization therapy

no-CRT

NO INTERVENTION

The no-CRT group receives a dual-chamber defibrillator

Interventions

cardiac resynchronization therapy PROCEDURE

Implantation of a CRT defibrillator with a standard right atrial, right ventricular defibrillator and left ventricular leads

CRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale Santa Maria di Loreto Mare: lead

Study Sites (1)

Ospedale Santa Maria di Loreto Mare

Naples, Italy

Location

Related Publications (1)

• Muto C, Solimene F, Gallo P, Nastasi M, La Rosa C, Calvanese R, Iengo R, Canciello M, Sangiuolo R, Diemberger I, Ciardiello C, Tuccillo B. A randomized study of cardiac resynchronization therapy defibrillator versus dual-chamber implantable cardioverter-defibrillator in ischemic cardiomyopathy with narrow QRS: the NARROW-CRT study. Circ Arrhythm Electrophysiol. 2013 Jun;6(3):538-45. doi: 10.1161/CIRCEP.113.000135. Epub 2013 Apr 16.

  PMID: 23592833 DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Carmine Muto, MD

  Ospedale Santa Maria di Loreto Mare

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Electrophysiology and Pacing Unit Director

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 13, 2012
• Study Start: January 1, 2008
• Primary Completion: August 1, 2012
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

IT (1)