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

October 15, 2016 updated by: Carmine Muto, Ospedale Santa Maria di Loreto Mare

Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy
        • Ospedale Santa Maria di Loreto Mare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Santa Maria di Loreto Mare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

April 11, 2012

First Submitted That Met QC Criteria

April 12, 2012

First Posted (Estimate)

April 13, 2012

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 15, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LM-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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