- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00900549
Evaluation of Resynchronization Therapy for Heart Failure (EARTH)
EvaluAtion of Resynchronization Therapy for Heart Failure (EARTH)
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
- QEII Health Sciences Centre
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Ontario
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Hamilton, Ontario, Canada, L8L 2X2
- Hamilton Health Sciences Center
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Ottawa, Ontario, Canada, K1Y 4W7
- University of Ottawa Heart Institute
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Toronto, Ontario, Canada, M5B 1W8
- St-Michael's Hospital
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook & Women's Hospital
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Quebec
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Fleurimont, Quebec, Canada, J1H 5N4
- CHUS-Fleurimont
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Montreal, Quebec, Canada, HIT1C8
- Montreal Heart Institute Research Center
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Montréal, Quebec, Canada, H2W 1T8
- CHUM-Hôpital Hotel-Dieu
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Montréal, Quebec, Canada, H4J 1C5
- Sacré-Cœur Hospital
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Québec, Quebec, Canada, G1V 4G5
- Institut Univ de Cardiologie et de Pneumologie de Québec
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The patients are eligible if they undergo an ICD implantation or replacement
- They have a documented LVEF ≤ 35% measured in the previous 6 months (without major clinical subsequent event, such as heart surgery, since the LVEF measurement)
- If measured by echocardiography, the LV end-diastolic diameter must be ≥ 60 mm
- The duration of the QRS is < 120 ms
- They are in sinus rhythm
- They cannot walk more than 400 meters during the screening 6-minute walk test (the patients must be limited by heart failure symptoms)
Exclusion Criteria:
Patients with an indication for permanent ventricular pacing or with chronotropic insufficiency defined as follow:
- 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 for the duration of the study
- Second or third degree AV block, either persistent or intermittent
- Patients with a pacemaker or an ICD who are paced in the ventricular chamber more than 5% of the time
- Patients with LV dysfunction associated with a reversible cause such as post-partum cardiomyopathy, tachycardia induced cardiomyopathy, acute myocarditis or acute toxic cardiomyopathy (including acute alcoholic)
Patients who had a myocardial infarction within the past 6 weeks* defined by 2 of the 3 following conditions:
- Prolonged chest pain
- ECG changes suggesting of AMI
- Cardiac enzymes elevation more than twice the local upper limit of normal)
- Patients who had cardiac surgery within the past 6 weeks*
- Patients with moderate or severe cardiac valve stenosis (aortic, mitral, pulmonary or tricuspid)
- Patients with an inability or a limitation to walk for reasons other than heart failure symptoms (e.g., angina, intermittent claudication, severe lung condition or arthrosis)
- Patients with severe coexisting illnesses making survival > 6 months unlikely
- Patients who are pregnant and/or nursing.
- Patients with inability or unwillingness to consent or comply with follow-up requirements
- Patients participating in another study
The 6-week period is calculated prior to the beginning of the baseline evaluation and not the implant procedure itself. This difference comes from the fact that the protocol includes a delay of 2 to 8 weeks between the implant procedure and the actual beginning of the patient's evaluation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CRT
|
12 months
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Sham Comparator: No CRT
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12-month
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total exercise duration at a constant submaximal load (defined as 75% of peak exercise during the baseline metabolic evaluation); study is powered to detect a min difference of 300 sec (+25% from baseline) in the primary endpoint between the 2 treatments
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical & electrical endpoints and echocardiographic & nuclear medicine evaluation of LV function. Dyssynchrony evaluation will help advancing the understanding of the physiopathology of heart failure and response to resynchronization therapy.
Time Frame: one year
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Bernard Thibault, MD, Montreal Heart Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCT67914 (Lesser Earth)
- ISRCTN 42560370
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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