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 |
| Protocol serial number | PG/2001084 |
| Sponsor | British Heart Foundation (UK) |
| Funder | British Heart Foundation (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | amiloride and spironolactone |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Key inclusion criteria | 1. Hypertensives of African origin 2. Subjects with the T594M polymorphism and controls with the wild-type sodium channel |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Blood Pressure Unit
London
SW17 0RE
United Kingdom
SW17 0RE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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
