Double Blind Crossover Comparison of Diuretics in the Young
Information source: University of Cambridge
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Low-Renin Hypertension
Intervention: Bendroflumethiazide 2.5mg - 5mg (Drug); Amiloride 20-40mg (Drug); Spironolactone 50-100mg (Drug); Frusemide 20-40mg (Drug); Bendroflumethiazide 1.25-2.5mg/ Amiloride 10-20mg combined (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Cambridge Official(s) and/or principal investigator(s):
Morris J Brown, Proffessor, Principal Investigator, Affiliation: Cambridge University
Overall contact:
Morris J Brown, Professor, Phone: 01223 336743, Email: mjb14@medschl.cam.ac.uk
Summary
The principle objective of the study is to determine whether low-renin (i. e. 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 different salt pumps, and each is blocked by a different type of
diuretic (salt losing tablet)If one out of the four is overactive, we would expect patients
to respond much better to one diuretic than to the alternatives - rather than responding
equally well to all available types of diuretic.
Clinical Details
Official title: Double Blind Crossover Comparison od Diuretics in Young Patients With Low Renin Hypertension
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Difference in systolic blood pressure for subjects' best drug and second best drug.Difference in plasma renin for subjects' best drug and second best drug.
Secondary outcome: Predictions of best drug
Detailed description:
Studies suggest that patients with low renin hypertension respond better to diuretics than
other hypertensive drug groups. The aim of the study is to rotate patients through the four
main diuretic groups and see if it is possible to identify the most effective diuretic for
this group, as measured by a >=10mgHg decrease in Systolic blood pressure in one specific
group a compared to the others.
As most caucasians with Low renin hypertension are older (>55), presentation with this type
of hypertension at a younger age suggests the presence of substantial genetic variation in
order to cause the atypical presentation. It is hoped that by identifying the best diuretic
for these patients we will also be able to identify:
1. Whether the young low-renin hypertensives can be sub-classified according to their most
effective diuretic;
2. Whether this sub-classification helps us to identify the genes and mutations
responsible, since these are to expected to be in the so-called sodium channels (i. e.
salt pumps)which the kidneys use to prevent salt being excreted in the urine.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Aged 18-45
- male or female
- Hypertensive - 3 clinic SBP >=140mmHg; or 3 clinic DBP >=90mmHg; or ABPM or home BP
>=130(SBP) or 85(DBP)
- 24hr Na+<160mmol/l
- EITHER {Plasma renin<=10mU/L (measured untreated, or whilst receiving only
CCB+/-diuretic} + {Plasma renin <=40mU/L (measured on an ACEi or ARB, which
approximately double s the plasma renin)} OR Plasma renin <5mU/L (measured untreated,
or receiving any antihypertensive drug other than a beta-blocker
Exclusion Criteria:
- Documented history of gout
- Abnormal renal function (both elevated serum creatinine and reduced creatinine
clearance
- SBP > 170mmHg or Diastolic >110mmHg despite treatment with permitted background
treatment
Locations and Contacts
Morris J Brown, Professor, Phone: 01223 336743, Email: mjb14@medschl.cam.ac.uk
University of Cambridge - Addenbrookes Hospital, Cambridge CB2 2QQ, United Kingdom; Recruiting
Morris J Brown, Proffessor, Phone: 01223 336743, Email: mjb14@medschl.cam.uk
Sue Hood, RGN - sister, Sub-Investigator
Diane Picton, RGN- sister, Sub-Investigator
Tim Burton, Phd, MRCP, Sub-Investigator
Additional Information
Starting date: August 2006
Ending date: July 2007
Last updated: January 31, 2007
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