Spironolactone AmiLoride Thiazide study of aldosterone sensitive hypertension

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Morris J Brown
Scientific

Clinical Pharmacology Unit
Level 6 ACCI
Box 110
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)1223 336743
Email	mjb14@medschl.cam.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SALT
Study objectives	Spironolactone will reduce systolic Blood Pressure (sBP) by more than 5 mmHg than bendrofluazide.
Ethics approval(s)	Ethics approval information not required at time of registration.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Spironolactone, amiloride, bendrofluazide and irbesartan.
Primary outcome measure(s)	sBP and plasma renin on spironolactone versus bendroflumethiazide.
Key secondary outcome measure(s)	1. sBP on amiloride versus other diuretics. 2. Further measures of natriuresis.
Completion date	01/09/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	60
Key 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
Key exclusion criteria	Contraindications to study drugs
Date of first enrolment	01/02/2003
Date of final enrolment	01/09/2005

Clinical Pharmacology Unit

Cambridge
CB2 2QQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	17/07/2007		Yes	No