Clinical Trial: Extracellular Fluid in Resistant Hypertension
This study is currently recruiting patients.
Verified by St George''''s, University of London August 2005
| Sponsored by: | St George''''s, University of London | | Information provided by: | St George''''s, University of London | | ClinicalTrials.gov Identifier: | NCT00141596 | |
Purpose
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.
| Condition | Intervention |
Hypertension
| Drug: Cardura XL 4 mg bd Drug: Amiloride 5 mg bd Drug: Furosemide 40 mg bd
|
MedlinePlus related topics: High Blood Pressure
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: A Study to Investigate the Contribution of Extracellular Fluid Volume Expansion to Drug Resistant Hypertension
Further Study Details:
Primary Outcomes: Change in ECV; change in BP
Expected Total Enrollment: 32
Study start: July 2003; Expected completion: October 2006
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
Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: 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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00141596
Timothy WR Doulton, BSc MRCP +44 208 725 3176 Ext. - tdoulton@sgul.ac.uk
United Kingdom Blood Pressure Unit, Dept.
Cardiac & Vascular Sciences, SGUL, London, SW17 0RE, United Kingdom; Recruiting
Timothy WR Doulton, BSc MRCP +44 208 725 3176 Ext. - tdoulton@sgul.ac.uk
Timothy WR Doulton, BSc MRCP, Principal Investigator
Study chairs or principal investigators
Timothy WR Doulton, BSc MRCP, Principal Investigator, SGUL
More Information
Study ID Numbers: LREC 03.0001
Last Updated: August 31, 2005
Record first received: August 31, 2005
ClinicalTrials.gov Identifier: NCT00141596
Health Authority: United Kingdom: Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-06
Source: ClinicalTrials.gov
Cache Date: September 7, 2005