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

First Received on August 31, 2005. Last Updated on May 10, 2007 History of Changes

Sponsor:	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

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:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure

Drug Information available for: Furosemide Doxazosin Doxazosin mesylate Amiloride

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov 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:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Amiloride
Furosemide
Doxazosin
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents

Therapeutic Uses
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 12, 2012