Condition category
Circulatory System
Date applied
28/03/2002
Date assigned
28/03/2002
Last edited
04/07/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Morris J Brown

ORCID ID

Contact details

Clinical Pharmacology Unit
Level 6 ACCI
Box 110
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 336743
mjb14@medschl.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PG/02/014/13511

Study information

Scientific title

Acronym

SALT

Study hypothesis

Spironolactone will reduce systolic Blood Pressure (sBP) by more than 5 mmHg than bendrofluazide.

Ethics approval

Ethics approval information not required at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Low-renin hypertension

Intervention

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).

Intervention type

Drug

Phase

Not Specified

Drug names

Spironolactone, amiloride, bendrofluazide and irbesartan.

Primary outcome measures

sBP and plasma renin on spironolactone versus bendroflumethiazide.

Secondary outcome measures

1. sBP on amiloride versus other diuretics.
2. Further measures of natriuresis.

Overall trial start date

01/02/2003

Overall trial end date

01/09/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Contraindications to study drugs

Recruitment start date

01/02/2003

Recruitment end date

01/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Pharmacology Unit
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

British Heart Foundation (UK)

Sponsor details

14 Fitzhardinge Street
London
W1H 6DH
United Kingdom
+44 (0)20 7935 0185
research@bhf.org.uk

Sponsor type

Charity

Website

http://www.bhf.org.uk/

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17606839

Publication citations

  1. Results

    Hood SJ, Taylor KP, Ashby MJ, Brown MJ, The spironolactone, amiloride, losartan, and thiazide (SALT) double-blind crossover trial in patients with low-renin hypertension and elevated aldosterone-renin ratio., Circulation, 2007, 116, 3, 268-275, doi: 10.1161/CIRCULATIONAHA.107.690396.

Additional files

Editorial Notes