Extracellular Fluid in Resistant Hypertension

This study has been terminated.
(Insufficient accrual rate)
Information provided by:
St George's, University of London
ClinicalTrials.gov Identifier:
First received: August 31, 2005
Last updated: June 5, 2015
Last verified: May 2007
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
Drug: Cardura XL 4 mg bd
Drug: Amiloride 5 mg bd
Drug: Furosemide 40 mg bd

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Investigate the Contribution of Extracellular Fluid Volume Expansion to Drug Resistant Hypertension

Resource links provided by NLM:

Further study details as provided by St George's, University of London:

Primary Outcome Measures:
  • Change in ECV; change in BP

Estimated Enrollment: 32
Study Start Date: July 2003
Study Completion Date: October 2006
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.

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00141596

United Kingdom
Blood Pressure Unit, Dept. Cardiac & Vascular Sciences, SGUL
London, United Kingdom, SW17 0RE
Sponsors and Collaborators
St George's, University of London
Principal Investigator: Timothy WR Doulton, BSc MRCP SGUL
  More Information

ClinicalTrials.gov Identifier: NCT00141596     History of Changes
Other Study ID Numbers: LREC 03.0001 
Study First Received: August 31, 2005
Last Updated: June 5, 2015
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by St George's, University of London:
Resistant Hypertension
Extracellular Fluid Volume

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 05, 2016