Extracellular Fluid in Resistant Hypertension
Information source: St George's, University of London
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Cardura XL 4 mg bd (Drug); Amiloride 5 mg bd (Drug); Furosemide 40 mg bd (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: St George's, University of London Official(s) and/or principal investigator(s):
Timothy WR Doulton, BSc MRCP, Principal Investigator, Affiliation: SGUL
Overall contact:
Timothy WR Doulton, BSc MRCP, Phone: +44 208 725 3176, Ext: -, Email: tdoulton@sgul.ac.uk
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.
Clinical Details
Official title: A Study to Investigate the Contribution of Extracellular Fluid Volume Expansion to Drug Resistant Hypertension
Study design: Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Change in ECV; change in BP
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Timothy WR Doulton, BSc MRCP, Phone: +44 208 725 3176, Ext: -, Email: tdoulton@sgul.ac.uk
Blood Pressure Unit, Dept. Cardiac & Vascular Sciences, SGUL, LONDON SW17 0RE, United Kingdom; Recruiting
Timothy WR Doulton, BSc MRCP, Phone: +44 208 725 3176, Ext: -, Email: tdoulton@sgul.ac.uk
Timothy WR Doulton, BSc MRCP, Principal Investigator
Additional Information
Starting date: July 2003
Ending date: October 2006
Last updated: May 10, 2007
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