Heart Failure, Systolic
Conditions
Keywords
CRT, heart failure, narrow QRS, dyssynchrony
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.
Interventions
Implantation of a CRT defibrillator with a standard right atrial, right ventricular defibrillator and left ventricular leads
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy