Condition category
Circulatory System
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
21/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Sue Hood

ORCID ID

Contact details

Clinical Pharmacology Unit
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3000

Study information

Scientific title

Double Blind Crossover Comparison of Diuretics in the Young

Acronym

Study hypothesis

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

MREC approved on the 7th July 2006 (ref: 06/MRE05/31)

Study design

Single centre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Bendroflumethiazide, amiloride, spironolactone, frusemide

Primary outcome measures

Difference in the fall in systolic blood pressure for each participant's best and second best drug

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2006

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 30

Participant 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

Recruitment start date

01/08/2006

Recruitment end date

01/01/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Pharmacology Unit
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

http://www.cuh.org.uk/research/research_index.html

Funders

Funder type

Charity

Funder name

British Heart Foundation (BHF) (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

21/07/2016: No publications found, verifying study status with principal investigator