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Double Blind Crossover Comparison of Diuretics in the Young

Double Blind Crossover Comparison od Diuretics in Young Patients With Low Renin Hypertension

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00429897
Enrollment
30
Registered
2007-02-01
Start date
2006-08-31
Completion date
2007-07-31
Last updated
2007-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low-Renin Hypertension

Keywords

Hypertension, Low Renin

Brief 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.

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.

Interventions

DRUGBendroflumethiazide 2.5mg - 5mg
DRUGAmiloride 20-40mg
DRUGSpironolactone 50-100mg
DRUGFrusemide 20-40mg
DRUGBendroflumethiazide 1.25-2.5mg/ Amiloride 10-20mg combined

Sponsors

British Heart Foundation
CollaboratorOTHER
University of Cambridge
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Predictions of best drug

Countries

United Kingdom

Contacts

Primary ContactMorris J Brown, Professor
mjb14@medschl.cam.ac.uk01223 336743

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026