Double Blind Crossover Comparison of Diuretics in the Young

ISRCTN ISRCTN28589999
DOI https://doi.org/10.1186/ISRCTN28589999
ClinicalTrials.gov number NCT00429897
Secondary identifying numbers 3000
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

Clinical Pharmacology Unit
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Study information

Study designSingle centre randomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleDouble Blind Crossover Comparison of Diuretics in the Young
Study objectivesThis 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) studiedTopic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Bendroflumethiazide, amiloride, spironolactone, frusemide
Primary outcome measureDifference in the fall in systolic blood pressure for each participant's best and second best drug
Secondary outcome measuresNot provided at time of registration
Overall study start date01/08/2006
Completion date01/01/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned sample size: 30
Key inclusion criteria1. 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 criteria1. 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 enrolment01/08/2006
Date of final enrolment01/01/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Clinical Pharmacology Unit
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Addenbrookes Hospital
Box 277, Hills Road
Cambridge
CB2 2QQ
England
United Kingdom

Website http://www.cuh.org.uk/research/research_index.html
ROR logo "ROR" https://ror.org/04v54gj93

Funders

Funder type

Charity

British Heart Foundation (BHF) (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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