Resynchronisation/defibrillation for Ambulatory heart Failure Trial

Completed

• Conditions: Congestive heart failure; Circulatory System

• Registration Number: ISRCTN16587532
• Lead Sponsor: niversity of Ottawa Heart Institute (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

Amended 06/03/2009:
Point 2 has been removed: 'Aged greater than or equal to 30, either sex'.

Initial information at the time of registration:
1. New York Heart Association (NYHA) class II
2. Aged greater than or equal to 30 years old, either sex
3. LVEF less than or equal to 30% by multiple gated acquisition (MUGA) scan or LVEF less than or equal to 30% and LV end diastolic dimension greater than 60 mm (by echocardiogram) within 6 months of randomisation
4. QRS duration greater than or equal to 120 ms
5. Optimal heart failure pharmacological therapy
6. ICD indication for primary or secondary prevention
7. Normal sinus rhythm OR chronic persistent atrial fibrillation with resting ventricular heart rate less than or equal to 60 bpm and ventricular rate less than or equal to 90 bpm during a 6-minute hall walk. This can be accomplished by pharmacological therapy or catheter AV Junction Ablation.

Exclusion Criteria

1. In hospital patients who have acute cardiac or non-cardiac cause
2. Intra-venous inotropic agent in the last 4 days
3. Patients with a life expectancy of less than 1 year non-cardiac cause
4. Expected to under go cardiac transplantation within 1 year (status I)
5. Patients with an acute coronary syndrome including myocardial infarction (MI) can be included if the patient has had a previous MI with LV dysfunction (LVEF less than or equal to 30%)
6. Unable or unwilling to provide informed consent
7. History of noncompliance of medical therapy
8. Uncorrected or uncorrectable primary valvular disease
9. Restrictive, hypertrophic or reversible form of cardiomyopathy
10. Severe primary pulmonary disease such as cor pulmonale
11. Tricuspid prosthetic valve
12. Patients included in other clinical trial that will affect the objectives of this study
13. Coronary revascularisation (coronary artery bypass graft [CABG] or percutaneous coronary intervention [PCI]) less than 1 month if previously determined LVEF greater than 30%. Patients with a more recent revascularisation can be included if a previous determined LVEF was less than or equal to 30%
14. Patients with an existing ICD (patients with an existing pacemaker may be included if the patients satisfies all other inclusion/exclusion criteria)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total mortality and hospitalisation for CHF. Total mortality includes any death. Hospitalisation for CHF is defined as an admission to hospital with a diagnosis of worsening CHF for greater than 24 hours.

Secondary Outcome Measures

Name	Time	Method
1. Cardiovascular mortality in comparison to total mortality same as above<br>2. Sudden arrhythmic death in comparison to total mortality as above<br>3. Progressive CHF death in comparison to total mortality same as above<br>4. All causes of hospitalisation rate<br>5. CHF hospitalisation rate throughout the length of the trial<br>6. Health related quality of life and cost economics using the MLWHF questionnaire and EQ5D questionnaire