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

• Sponsor: Ospedale Santa Maria di Loreto Mare (Other)
• Overall Status: Completed
• CT.gov ID: NCT01577446
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Systolic	Procedure: cardiac resynchronization therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Aug 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. heart failure clinical composite score [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.

Secondary Outcome Measures

1. time to the first heart failure hospitalization or death [up to 30 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carmine Muto, Electrophysiology and Pacing Unit Director, Ospedale Santa Maria di Loreto Mare
• ClinicalTrials.gov Identifier: NCT01577446
• Other Study ID Numbers: LM-002
• First Posted: Apr 13, 2012
• Last Update Posted: Oct 18, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by Carmine Muto, Electrophysiology and Pacing Unit Director, Ospedale Santa Maria di Loreto Mare: CRT; heart failure; narrow QRS; dyssynchrony
• Additional relevant MeSH terms: Heart Failure; Heart Failure, Systolic

Study Results

No Results Posted as of Oct 18, 2016