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

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.

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Key information

Conditions

Heart Failure, Systolic Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Santa Maria di Loreto Mare

Naples, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac resynchronization therapy

Procedure

Implantation of a CRT defibrillator with a standard right atrial, right ventricular defibrillator and left ventricular leads

Primary outcomes

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.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Ospedale Santa Maria di Loreto Mare

Other

Registry information

Official study title

Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy

Acronym: NARROW-CRT

Important dates

Study start: 2008
Primary completion: 2012
First posted: Apr 13, 2012
Registry last updated: Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed