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...
Date First Received: August 31, 2005
Last Updated: May 10, 2007
Verified by: St George's, University of London, May 2007
Clinical Trial Phase: N/A | Start Date: July 2003
Overall Status: Recruiting
Estimated Enrollment: 32
Brief Summary
Official Title: “A Study to Investigate the Contribution of Extracellular Fluid Volume Expansion to Drug Resistant Hypertension”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Cardura XL 4 mg bd
- Drug: Amiloride 5 mg bd
- Drug: Furosemide 40 mg bd
Outcome Measures for this Clinical Trial
Primary Measures
- Change in ECV; change in BP
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: St George's, University of London
Overall Clinical Trial Officials and Contacts
Timothy WR Doulton, BSc MRCP Principal Investigator SGUL
Overall Contact: Timothy WR Doulton, BSc MRCP +44 208 725 3176 tdoulton@sgul.ac.uk
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00141596
Study ID Number: LREC 03.0001
ClinicalTrials.gov Identifier: NCT00141596
Health Authority: United Kingdom: Research Ethics Committee
Clinical Trials Authorship and Review
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