Extracellular Fluid in Resistant Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2006-10-31

Brief Summary

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The optimal treatment of drug resistant (defined as BP\> 140/85 despite three anti-hypertensive drugs including a diuretic) is not well defined. This study aims to test the hypothesis that resistant hypertension is caused by excessive expansion of extracellular fluid volume. A secondary objective is to study which of three different antihypertensive drugs would be most useful in drug resistant hypertension.

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Detailed Description

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Following recruitment subjects will have ECV measured by 51Cr-EDTA determination of GFR, with Brochner-Mortensen correction applied. Subjects then receive the following drugs, in a randomised fashion, for a period of four weeks each, with BP \& ECV measurement at end of each period: doxazosin GITS (Cardura XL) 4 mg b.d.; frusemide 40 mg b.d.; amiloride 5 mg b.d.; placebo.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cardura XL 4 mg bd

Intervention Type DRUG

Amiloride 5 mg bd

Intervention Type DRUG

Furosemide 40 mg bd

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BP \>140/85
* 3 antihypertensive drugs (ACE/ARB + calcium channel blocker + thiazide diuretic)

Exclusion Criteria

* Pregnancy
* Breast Feeding
* Unstable heart failure
* Chronic Liver Disease
* Creatinine \>120 mcmol/L
* Contraindication to (or intolerance of) drug used in study
* BP \> 180/110

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No