Extracellular Fluid in Resistant Hypertension

Not Applicable

Terminated

• Conditions: Hypertension

• Registration Number: NCT00141596
• Lead Sponsor: St George's, University of London

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-01
• Study Completion: 2006-10
• Status Verified: 2007-05
• Last Update Submitted: 2015-06-05
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in ECV; change in BP

Trial Locations

Locations (1)

Blood Pressure Unit, Dept. Cardiac & Vascular Sciences, SGUL; 🇬🇧 London, United Kingdom