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ISRCTN
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ISRCTN70010120
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ClinicalTrials.gov identifier
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Public title
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Does aldosterone blockade improve endothelial dysfunction in patients with coronary artery disease but without heart failure?
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Scientific title
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Acronym
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N/A
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Serial number at source
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Sha001
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Study hypothesis
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Aldosterone blockade improves endothelial function in patients with coronary artery disease without heart failure
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Lay summary
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Ethics approval
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Approved by the Regional Research Ethics Committee on 09/07/2004, reference number: 04/S1401/82
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Study design
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Randomised, double-blind, placebo-controlled crossover trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Coronary artery disease
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Participants - inclusion criteria
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1. Patient with known coronary artery disease
2. Chronic stable angina
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Participants - exclusion criteria
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1. Left ventricular systolic dysfunction
2. Renal failure
3. Hyperkalaemia
4. Warfarin therapy
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Anticipated start date
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05/01/2005
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Anticipated end date
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31/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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88
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Interventions
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Spironolactone versus placebo
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Primary outcome measure(s)
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Improvement in endothelial function
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Secondary outcome measure(s)
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1. Changes in brain natriuretic peptide (BNP)
2. Amino-terminal propeptide of type III procollagen (PIIINP)
3. Angiotensin converting enzyme (ACE) activity
4. Heart rate variability
5. QT dispersion
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Sources of funding
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British Hearth Foundation
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Trial website
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Publications
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Contact name
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Dr
Nimit
Shah
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Address
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Department of Clinical Pharmacology
Level 7
Ninewells Hospital
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City/town
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Dundee
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Zip/Postcode
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DD1 9SY
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Country
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United Kingdom
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Sponsor
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University of Dundee (UK)
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Address
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Department of Clinical Pharmacology
Level 7
Ninewells Hospital
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City/town
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Dundee
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Zip/Postcode
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DD1 9SY
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Country
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United Kingdom
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Date applied
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21/02/2006
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Last edited
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07/12/2010
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Date ISRCTN assigned
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29/03/2006
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