Extracellular Fluid in Resistant Hypertension - Tabular View

Tracking Information

First Received Date ^ICMJE

August 31, 2005

Last Updated Date

May 10, 2007

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change in ECV; change in BP

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00141596 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Extracellular Fluid in Resistant Hypertension

Official Title ^ICMJE

A Study to Investigate the Contribution of Extracellular Fluid Volume Expansion to Drug Resistant Hypertension

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Cardura XL 4 mg bd
Drug: Amiloride 5 mg bd
Drug: Furosemide 40 mg bd

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

October 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Timothy WR Doulton, BSc MRCP

+44 208 725 3176 ext -

tdoulton@sgul.ac.uk

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00141596

Responsible Party

Study ID Numbers ^ICMJE

LREC 03.0001

Study Sponsor ^ICMJE

St George's, University of London

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Timothy WR Doulton, BSc MRCP

SGUL

Information Provided By

St George's, University of London

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP