Double Blind Crossover Comparison of Diuretics in the Young
| ISRCTN | ISRCTN28589999 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28589999 |
| ClinicalTrials.gov (NCT) | NCT00429897 |
| Protocol serial number | 3000 |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust (UK) |
| Funder | British Heart Foundation (BHF) (UK) |
- Submission date
- 12/05/2010
- Registration date
- 12/05/2010
- Last edited
- 01/02/2019
- 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
Mrs Sue Hood
Scientific
Scientific
Clinical Pharmacology Unit
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Double Blind Crossover Comparison of Diuretics in the Young |
| Study objectives | This clinical trial aims to determine whether low-renin (ie salt sensitive) hypertension at a young age is caused by the kidneys hanging onto too much salt as a result of an over-active salt pump in the kidney. The kidneys have four salt pumps, and each is blocked by a different type of diuretic (salt losing) tablet. If one of the four is overactive we would expect patients to respond much better to one diuretic than to the alternative- rather than responding equally well to all types of diuretic. The study also aims to determine genetic mutations responsible for low-renin hypertension. |
| Ethics approval(s) | MREC approved on the 7th July 2006 (ref: 06/MRE05/31) |
| Health condition(s) or problem(s) studied | Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular |
| Intervention | Patients will receive, in a random order, 5 blocks of 5 week treatments consisting of: 1. Bendroflumethiazide 2.5 - 5 mg 2. Amiloride 20 - 40 mg 3. Spironolactone 50 - 100 mg 4. Frusemide 20 - 40 mg 5. A combination of bendroflumethiazide 1.25 - 2.5 mg and amiloride 10 - 20 mg There will be a forced titration from lower to the higher dose half way through each dosing period. Each phase will start with two days of placebo treatment. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bendroflumethiazide, amiloride, spironolactone, frusemide |
| Primary outcome measure(s) |
Difference in the fall in systolic blood pressure for each participant's best and second best drug |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Aged 18 - 45 years 2. Male or female 3. Hypertensive: 3.1. Three clinic systolic blood pressure (SBP) greater than or equal to 140 mmHg; or 3.2. Three clinic diastolic blood pressure (DBP) greater than or equal to 90 mmHg; or 3.3. Ambulatory blood pressure monitoring (ABPM) or home blood pressure (BP) greater than or equal to 130 mmHg (SBP) or 85 mmHg (DBP) 4. 24-hour Na+ less than 160 mmol/l 5. Either: 5.1. Plasma renin less than or equal to 10 mU/L (measured untreated, or whilst receiving only CCB+/-diuretic) + plasma renin less than or equal to 40 mU/L (measured on an ACEi or ARB, which approximately doubles the plasma renin); or 5.2. Plasma renin less than 5 mU/L (measure untreated) 6. Receiving any antihypertensive drug other than a beta-blocker |
| Key exclusion criteria | 1. Documented history of gout 2. Abnormal renal function (both elevated serum creatinine and reduced creatinine clearance) 3. SBP greater than 170 mmHg or DBP greater than 110 mmHg despite treatment with permitted background treatment |
| Date of first enrolment | 01/08/2006 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Clinical Pharmacology Unit
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
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
01/02/2019: No publications found, verifying study status with the principal investigator
21/12/2018: NCT code added.
21/07/2016: No publications found, verifying study status with principal investigator
