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Extracellular Fluid in Resistant Hypertension

Information source: St George's, University of London
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Cardura XL 4 mg bd (Drug); Amiloride 5 mg bd (Drug); Furosemide 40 mg bd (Drug)

Phase: N/A

Status: Terminated

Sponsored by: St George's, University of London

Official(s) and/or principal investigator(s):
Timothy WR Doulton, BSc MRCP, Principal Investigator, Affiliation: SGUL

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.

Clinical Details

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

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

Primary outcome: Change in ECV; change in BP

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Blood Pressure Unit, Dept. Cardiac & Vascular Sciences, SGUL, London SW17 0RE, United Kingdom
Additional Information

Starting date: July 2003
Last updated: June 5, 2015

Page last updated: August 23, 2015

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