Double blind, randomised controlled cross over trial comparing the antihypertensive effects of amiloride and spironolactone in black hypertensives with and without the T594M mutation
| ISRCTN | ISRCTN21821912 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21821912 |
| Secondary identifying numbers | PG/2001084 |
- Submission date
- 08/03/2002
- Registration date
- 08/03/2002
- Last edited
- 14/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr PA Swift
Scientific
Scientific
Blood Pressure Unit
Department of Physiological Medicine
St George's Hospital Medical School
Cranmer Terrace
London
SW17 0RE
United Kingdom
| Phone | +44 20 8725 3176 |
|---|---|
| pswift@sghms.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | Double blind, randomised controlled cross over trial comparing the antihypertensive effects of amiloride and spironolactone in black hypertensives with and without the T594M mutation |
| Study hypothesis | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Hypertension |
| Intervention | 1. Amiloride 5 mg bd for 2 weeks, increased to 10 mg bd for further 6 weeks. Then cross over to spironolactone as below, then to a combination of amiloride 5 mg bd plus spironolactone 25 mg bd 2. Spironolactone 25 mg bd for 2 weeks then increased to 50 mg bd for further 6 weeks. Then cross over to amiloride as above, then to a combination of amiloride 5 mg bd plus spironolactone 25 mg bd |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | amiloride and spironolactone |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2002 |
| Overall study end date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Participant inclusion criteria | 1. Hypertensives of African origin 2. Subjects with the T594M polymorphism and controls with the wild-type sodium channel |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 01/01/2002 |
| Recruitment end date | 31/12/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Blood Pressure Unit
London
SW17 0RE
United Kingdom
SW17 0RE
United Kingdom
Sponsor information
British Heart Foundation (UK)
Charity
Charity
14 Fitzhardinge Street
London
W1H 6DH
United Kingdom
| Phone | +44 (0)20 7935 0185 |
|---|---|
| research@bhf.org.uk | |
| Website | http://www.bhf.org.uk/ |
"ROR" |
https://ror.org/02wdwnk04 |
Funders
Funder type
Charity
British Heart Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
14/03/2017: No publications found in PubMed, verifying study status with principal investigator
