Evaluation of resynchronization therapy for heart failure (EARTH)
- Conditions
- Heart failureCirculatory System
- Registration Number
- ISRCTN42560370
- Lead Sponsor
- Montréal Heart Institute (Canada)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 240
Correct and updated information as of 05/06/2009:
Patient must answer yes to the following questions:
1. Does the patient require an ICD or an ICD replacement?
2. Does the patient have a documented left ventricular ejection fraction (LVEF) less than or equal to 35% measured in the previous 6 months (without major concomitant clinical event)?
3. Does the patient have a QRS duration of less than 120 ms?
4. Is the patient in sinus rhythm?
5. Was the six-minute walk test distance less than 400 meters and limited by heart failure symptoms?
Initial (incorrect) information at time of registration:
1. Diagnosis of asthma verified by primary care MD.
2. Aged greater than or equal to 18 years old, either sex
3. Asthma managed by primary care MD and receiving asthma drug therapy from primary care MD
Amended as of 05/06/2009:
Point one of the below exclusion criteria has been amended as follows:
1. Indication for permanent pacing or with chronotropic insufficiency defined as follows:
1.1. Any condition where the treating physician believes it would not be acceptable for the patient to have his device NOT programmed with the SENSOR at ON
1.2. Second or third degree AV block, either persistent or intermittent block
1.3. Patients with a pacemaker or an ICD who are paced in either chamber (A or V) more than 5% of the time
Initial information at time of registration:
1. Indication for permanent pacing or with chronotropic insufficiency defined as follows:
1.1. Severe sinus bradycardia (resting heart rate less than 50/min)
1.2. Chronotropic insufficiency, defined as a heart rate during the screening 6-minute walk test that does not increase by more than 10 beats/minute compared to the resting rate
1.3. First degree AV block with a PR interval greater than 250 ms, Second or third degree AV block, either persistent or intermittent
1.4. Patients with a pacemaker or an ICD who are paced in either chamber (A or V) more than 5% of theme
2. LV dysfunction associated with a reversible cause such as post-partum cardiomyopathy, tachycardia induced cardiomyopathy, acute myocarditis or acute toxic cardiomyopathy (including acute alcoholic)
3. Myocardial infarction within the past 6 weeks (defined by two of the three following conditions: prolonged chest pain, electrocardiogram (ECG) changes suggesting of acute myocardial infarction (AMI) or cardiac enzymes elevation more than twice the local upper limit of normal)
4. Cardiac surgery within the past 6 weeks
5. Coronary angioplasty within the past 6 months
6. Moderate or severe cardiac valve stenosis
7. Inability or a limitation to walk for reasons other than heart failure symptoms (e.g. angina, intermittent claudication, severe lung condition or arthrosis)
8. Severe coexisting illnesses making survival greater than 6 months unlikely
9. Pregnancy and/or nursing
10. Inability or unwillingness to consent or comply with follow-up requirements
11. Participation in another study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total exercise duration at constant sub-maximal load (defined as 75% of peak exercise during the baseline metabolic evaluation).
- Secondary Outcome Measures
Name Time Method <br> 1. Clinical endpoints (Quality of Life [QoL], New York Heart Association [NYHA])<br> 2. Electrical endpoints (ECG)<br> 3. Echocardiographic endpoints (LVEF and volumes)<br> 4. MUGA scan endpoints (LVEF and synchrony index)<br> 5. Neuro-hormones (brain natriuretic peptide [BNP], atrial natriuretic peptide [ANP])<br>