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ISRCTN
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ISRCTN85520592
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ClinicalTrials.gov identifier
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Public title
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Spironolactone AmiLoride Thiazide study of aldosterone sensitive hypertension
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Scientific title
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Acronym
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SALT
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Serial number at source
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PG/02/014/13511
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Study hypothesis
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Spironolactone will reduce systolic Blood Pressure (sBP) by more than 5 mmHg than bendrofluazide.
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Ethics approval
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Ethics approval information not required at time of registration.
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Study design
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Randomised controlled 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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Low-renin hypertension
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Participants - inclusion criteria
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1. Hypertension (requiring treatment according to British Hypertension Society [BHS] criteria)
2. Aldosterone/renin ratio >400
3. Either Systolic Blood Pressure (SBP) on spironolactone more than or equal to 20 mmHg, during previous open-label treatment or Plasma renin activity less than 0.2 pmol/ml/h and response to spironolactone not previously tested
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Participants - exclusion criteria
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Contraindications to study drugs
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Anticipated start date
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01/02/2003
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Anticipated end date
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01/09/2005
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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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60
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Interventions
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Spironolactone (50 & 100 mg), amiloride (20 & 40 mg), bendrofluazide (2.5 & 5 mg), irbesartan (150 mg), placebo.
The lower dose of each will be re-encapsulated in identical capsules. Patients will take two capsules each day, consisting of either two placebos, or one each active and placebo (ie low-dose active), or two active (ie high-dose active).
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Primary outcome measure(s)
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sBP and plasma renin on spironolactone versus bendroflumethiazide.
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Secondary outcome measure(s)
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1. sBP on amiloride versus other diuretics.
2. Further measures of natriuresis.
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Sources of funding
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British Heart Foundation (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17606839
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Contact name
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Prof
Morris J
Brown
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Address
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Clinical Pharmacology Unit
Level 6 ACCI
Box 110
Addenbrooke's Hospital
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QQ
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Country
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United Kingdom
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Tel
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+44 (0)1223 336743
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Fax
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+44 (0)1223 762576
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Email
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mjb14@medschl.cam.ac.uk
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Sponsor
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British Heart Foundation (UK)
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Address
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14 Fitzhardinge Street
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City/town
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London
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Zip/Postcode
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W1H 6DH
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Country
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United Kingdom
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Tel
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+44 (0)20 7935 0185
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Fax
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+44 (0)20 7486 5820
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Email
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research@bhf.org.uk
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Sponsor website:
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http://www.bhf.org.uk/
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Date applied
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28/03/2002
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Last edited
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04/07/2007
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Date ISRCTN assigned
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28/03/2002
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