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
Sponsor:
Information provided by:
St George's, University of London
ClinicalTrials.gov Identifier:
NCT00141596
First received: August 31, 2005
Last updated: May 10, 2007
Last verified: May 2007
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014