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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Ospedale Santa Maria di Loreto Mare.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Carmine Muto, Ospedale Santa Maria di Loreto Mare
ClinicalTrials.gov Identifier:
NCT01577446
First received: April 11, 2012
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Kaplan-Meier analysis is used to analyze time to death or first heart failure hospitalization


Estimated Enrollment: 120
Study Start Date: January 2008
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577446

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

No publications provided by Ospedale Santa Maria di Loreto Mare

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carmine Muto, Electrophysiology and Pacing Unit Director, Ospedale Santa Maria di Loreto Mare
ClinicalTrials.gov Identifier: NCT01577446     History of Changes
Other Study ID Numbers: LM-002
Study First Received: April 11, 2012
Last Updated: April 12, 2012
Health Authority: Italy: Ministry of Health

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

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014