NCT00141596

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jul 2003

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

June 9, 2015

Status Verified

May 1, 2007

First QC Date

August 31, 2005

Last Update Submit

June 5, 2015

Conditions

Hypertension

Keywords

Resistant HypertensionExtracellular Fluid Volume

Outcome Measures

Primary Outcomes (1)

  • Change in ECV; change in BP

Interventions

Cardura XL 4 mg bdDRUG
Amiloride 5 mg bdDRUG
Furosemide 40 mg bdDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BP \>140/85
  • antihypertensive drugs (ACE/ARB + calcium channel blocker + thiazide diuretic)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blood Pressure Unit, Dept. Cardiac & Vascular Sciences, SGUL

London, SW17 0RE, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Interventions

DoxazosinAmilorideFurosemide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PrazosinQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrazinesHeterocyclic Compounds, 1-RingSulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • Timothy WR Doulton, BSc MRCP

    SGUL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 1, 2005

Study Start

July 1, 2003

Study Completion

October 1, 2006

Last Updated

June 9, 2015

Record last verified: 2007-05

Locations

GB(1)