Extracellular Fluid in Resistant Hypertension - Full Text View

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

Drug Information available for: Amiloride Doxazosin Doxazosin mesylate Furosemide

U.S. FDA Resources

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 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.

Eligibility

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

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

Contacts and Locations

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

Contacts

Contact: Timothy WR Doulton, BSc MRCP

+44 208 725 3176 ext -

tdoulton@sgul.ac.uk

Locations

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 - tdoulton@sgul.ac.uk
Principal Investigator: Timothy WR Doulton, BSc MRCP

Sponsors and Collaborators

St George's, University of London

Investigators

Principal Investigator:

Timothy WR Doulton, BSc MRCP

SGUL

More Information

Study ID Numbers:	LREC 03.0001
Study First Received:	August 31, 2005
Last Updated:	May 10, 2007
ClinicalTrials.gov Identifier:	NCT00141596
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by St George's, University of London:

Resistant Hypertension
Extracellular Fluid Volume

Study placed in the following topic categories:

Amiloride
Vascular Diseases
Furosemide
Doxazosin
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009