Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy (NARROW CRT)
This study is ongoing, but not recruiting participants.
Sponsor:
Ospedale Santa Maria di Loreto Mare
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
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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 More Information
No publications provided
| 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 Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013