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Extracellular Fluid in Resistant Hypertension

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by St George's, University of London.
Recruitment status was  Recruiting
Information provided by:
St George's, University of London Identifier:
First received: August 31, 2005
Last updated: May 10, 2007
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
Estimated 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00141596

Contact: Timothy WR Doulton, BSc MRCP +44 208 725 3176 ext -

United Kingdom
Blood Pressure Unit, Dept. Cardiac & Vascular Sciences, SGUL Recruiting
London, United Kingdom, SW17 0RE
Contact: Timothy WR Doulton, BSc MRCP    +44 208 725 3176 ext -   
Principal Investigator: Timothy WR Doulton, BSc MRCP         
Sponsors and Collaborators
St George's, University of London
Principal Investigator: Timothy WR Doulton, BSc MRCP SGUL
  More Information

No publications provided Identifier: NCT00141596     History of Changes
Other Study ID Numbers: LREC 03.0001
Study First Received: August 31, 2005
Last Updated: May 10, 2007
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 processed this record on February 27, 2015