Assessment of cardiac resynchronization therapy in patients with wide QRS-complex and non-specific intraventricular conduction delay: a randomized trial.

Conditions: Heart failure
10019280

Registration Number: NL-OMON54616

Lead Sponsor: Clermont-Ferrand University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Patients over 18 years* old
- NYHA class II to IV ambulatory
- QRS duration > 130 ms
- Patients with sinus rhythm
- LVEF < 35%
- QRS morphology: NICD according to the AHA/ACCF/HRS Recommendations (non-LBBB
and non-RBBB):
o Not broad notched or slurred R wave in leads I, aVL, V5 and V6;
o Presence of a Q wave in leads I, V5, V6;
o No rsr*, rsR* or rSR* pattern in leads V1 or V2.
- Life expectancy expected to exceed one year with a good functional status
- Optimal pharmacological therapy of heart failure according to clinician

Exclusion Criteria

- Inability to understand nor decline the study,
- Impaired mobility,
- Unable to fill out questionnaire independently,
- Patients with permanent atrial fibrillation,
- Pregnant women,
- Dependant adult,
- Patients minor,
- Life expectancy < 1 year due to other causes than HF.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Composite of 2 clinical endpoints (12 months all-cause deaths and percentage of<br /><br>hospitalizations for HF at 12 months) combined using an average z-score.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Evaluation of efficacy, analysis of:<br /><br>- 12- month deaths (HF, cardiovascular and all causes deaths),<br /><br>- Quality-of-life questionnaires at 6 and 12 months:<br /><br>o Minnesota Living With Heart Failure Questionnaire: MLWHFQ): improvement of at<br /><br>least 20 points<br /><br>- Functional capacity at 6 and 12 months:<br /><br>o NYHA classification reduction >= 1 class,<br /><br>o 6-minute walk test improvement of at least 10 % in distance,<br /><br>o Peak oxygen consumption increased by 1.0 ml/kg/min13,<br /><br>- Percentage of hospitalizations for HF, for cardiovascular reasons and for all<br /><br>causes at 6 and 12 months,<br /><br>- Decrease >15% in end-diastolic and/or end-systolic volumes of the left<br /><br>ventricle at 6 and 12 months.</p><br>