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

Heart Failure, Systolic Clinical Trial

— NARROW-CRT  

Official title:

Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577446
• Other study ID #: LM-002
• Status: Completed
• Phase: N/A
• First received: April 11, 2012
• Last updated: October 15, 2016
• Start date: January 2008

Study information

• Verified date: October 2016
• Source: Ospedale Santa Maria di Loreto Mare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

Procedure:
• cardiac resynchronization therapy
Implantation of a CRT defibrillator with a standard right atrial, right ventricular defibrillator and left ventricular leads

Locations

Country	Name	City	State
Italy	Ospedale Santa Maria di Loreto Mare	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Santa Maria di Loreto Mare

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	time to the first heart failure hospitalization or death	Kaplan-Meier analysis is used to analyze time to death or first heart failure hospitalization	up to 30 months	No