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NCT00141596 Clinical Trial

Extracellular Fluid in Resistant Hypertension

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00141596
Other study ID # LREC 03.0001
Secondary ID
Status Terminated
Phase N/A
First received August 31, 2005
Last updated June 5, 2015
Start date July 2003
Est. completion date October 2006

Study information
Verified date May 2007
Source St George's, University of London
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 32
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Cardura XL 4 mg bd

• Amiloride 5 mg bd

• Furosemide 40 mg bd

Locations
Country Name City State
United Kingdom Blood Pressure Unit, Dept. Cardiac & Vascular Sciences, SGUL London

Sponsors (1)
Lead Sponsor Collaborator
St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in ECV; change in BP
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