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

Primary Purpose

Heart Failure, Systolic

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
cardiac resynchronization therapy
Sponsored by
Ospedale Santa Maria di Loreto Mare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Systolic focused on measuring CRT, heart failure, narrow QRS, dyssynchrony

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Santa Maria di Loreto Mare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CRT

no-CRT

Arm Description

The CRT group undergoes implantation of a CRT defibrillator

The no-CRT group receives a dual-chamber defibrillator

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 11, 2012
Last Updated
October 15, 2016
Sponsor
Ospedale Santa Maria di Loreto Mare
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1. Study Identification

Unique Protocol Identification Number
NCT01577446
Brief Title
Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy (NARROW CRT)
Acronym
NARROW-CRT
Official Title
Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Santa Maria di Loreto Mare

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic
Keywords
CRT, heart failure, narrow QRS, dyssynchrony

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT
Arm Type
Experimental
Arm Description
The CRT group undergoes implantation of a CRT defibrillator
Arm Title
no-CRT
Arm Type
No Intervention
Arm Description
The no-CRT group receives a dual-chamber defibrillator
Intervention Type
Procedure
Intervention Name(s)
cardiac resynchronization therapy
Intervention Description
Implantation of a CRT defibrillator with a standard right atrial, right ventricular defibrillator and left ventricular leads
Primary Outcome Measure Information:
Title
heart failure clinical composite score
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
time to the first heart failure hospitalization or death
Description
Kaplan-Meier analysis is used to analyze time to death or first heart failure hospitalization
Time Frame
up to 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmine Muto, MD
Organizational Affiliation
Ospedale Santa Maria di Loreto Mare
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Santa Maria di Loreto Mare
City
Naples
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
23592833
Citation
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.
Results Reference
derived

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

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