| Source of record | UK Trials |
| ISRCTN | ISRCTN85520592 |
| Date ISRCTN assigned | 28/03/2002 |
| Local reference number(s) | PG/02/014/13511 |
| Public title | Spironolactone AmiLoride Thiazide study of aldosterone sensitive hypertension |
| Scientific title |
|
| Acronym | SALT |
| Disease/condition/study domain | Low-renin hypertension |
| Study hypothesis | Spironolactone will reduce systolic Blood Pressure (sBP) by more than 5 mmHg than bendrofluazide. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics approval information not required at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 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 |
| Participants - exclusion criteria | Contraindications to study drugs |
| Patient information material |
|
| Anticipated start date | 01/02/2003 |
| Anticipated end date | 01/09/2005 |
| Status of trial | Completed |
| Target number of participants | 60 |
| Interventions | 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). |
| Primary outcome measure(s) | sBP and plasma renin on spironolactone versus bendroflumethiazide. |
| Secondary outcome measure(s) | 1. sBP on amiloride versus other diuretics.
2. Further measures of natriuresis. |
| Publications | Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17606839 |
| Sources of funding | British Heart Foundation (UK) |
| Sponsor name | British Heart Foundation (UK) |
| Sponsor details | 14 Fitzhardinge Street
London
United Kingdom
W1H 6DH |
| Sponsor telephone | +44 (0)20 7935 0185 |
| Sponsor fax | +44 (0)20 7486 5820 |
| Sponsor email | research@bhf.org.uk |
| Sponsor website | http://www.bhf.org.uk/ |
| Contact name | Prof Morris J Brown |
| Contact details | Clinical Pharmacology Unit
Level 6 ACCI
Box 110
Addenbrooke's Hospital
Cambridge
United Kingdom
CB2 2QQ |
| Contact telephone | +44 (0)1223 336743 |
| Contact fax | +44 (0)1223 762576 |
| Contact email | mjb14@medschl.cam.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN85520592 |
| Date last extracted from ISRCTN register | 17/04/2008 |
