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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00505336 |
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Date of registration:
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19/07/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Eplerenone and Atorvastatin on Markers of Collagen Turnover in Diastolic Heart Failure
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Scientific title:
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The Effect of Eplerenone and Atorvastatin on Markers of Collagen Turnover in Diastolic Heart Failure |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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43 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00505336 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Ireland
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Contacts
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Name:
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George Mak, MB MRCPI |
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Address:
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Telephone:
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Email:
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Affiliation:
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St Vincent's University Hospital |
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Name:
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Ken McDonald, MD FRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Heart Failure Unit, St Vincent's University Hospital |
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Name:
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Niamh Murphy, MD MRCPI |
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Address:
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Telephone:
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Email:
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Affiliation:
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St Vincent's University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with diastolic heart failure.
- Diastolic heart failure is defined as symptoms of heart failure with an ejection
fraction >45%, BNP >100pg/ml and Doppler evidence of diastolic dysfunction.
Exclusion Criteria:
- Clinically unstable as defined by any change in diuretic dose in the month prior to
enrolment.
- Evidence of significant inflammatory disease or hepatic disease or metabolic bone
disease which may alter parameters of collagen metabolism.
- Patients already receiving statin, aldosterone or eplerenone therapy
- Pregnant women and women of child bearing age
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diastolic Heart Failure
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Intervention(s)
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Other: No additional treatment
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Drug: Atorvastatin
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Drug: Eplerenone
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Primary Outcome(s)
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To investigate the impact of aldosterone antagonism or statin therapy on markers of collagen turnover in patients with diastolic heart failure.
[Time Frame: 12 months]
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Secondary Outcome(s)
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To assess the impact of aldosterone antagonism or statin therapy on markers of diastolic dysfunction by echocardiography
[Time Frame: 12 months]
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To assess the impact of aldosterone antagonism or statin therapy on indices of clinical well being
[Time Frame: 12 months]
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The assess the impact of aldosterone antagonism or statin therapy on diastolic indices by cardiac MRI
[Time Frame: 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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