HypertensionNCT00141596
Extracellular Fluid in Resistant Hypertension
A study testing Cardura XL 4 mg bd, Amiloride 5 mg bd and Furosemide 40 mg bd in people with Hypertension, run by St George's, University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Cardura XL 4 mg bd, Amiloride 5 mg bd and Furosemide 40 mg bd
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2003to Oct 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BP >140/85
- 3 antihypertensive drugs (ACE/ARB + calcium channel blocker + thiazide diuretic)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Blood Pressure Unit, Dept. Cardiac & Vascular Sciences, SGUL
London, SW17 0RE
About this study
Official title: A Study to Investigate the Contribution of Extracellular Fluid Volume Expansion to Drug Resistant Hypertension
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Cardura XL 4 mg bd, Amiloride 5 mg bd, Furosemide 40 mg bd
- Keywords
- Resistant Hypertension, Extracellular Fluid Volume
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardura XL 4 mg bdDrug
Amiloride 5 mg bdDrug
Furosemide 40 mg bdDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ECV; change in BP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startJul 2003
- Study completionOct 2006
Why it stopped: Insufficient accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Investigators
- Timothy WR Doulton, BSc MRCP, Principal investigator, SGUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141596
- Sponsor's protocol ID
- LREC 03.0001
- Status last verified
- May 2007
- First submitted
- 31 Aug 2005
- Last updated
- 9 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Contribution of Extracellular Fluid Volume Expansion to Drug Resistant Hypertension
- ClinicalTrials.gov ID
- NCT00141596
- Acronym / sponsor ID
- LREC 03.0001
- Conditions
- Hypertension
- Keywords
- Resistant Hypertension, Extracellular Fluid Volume
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient accrual rate
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Jul 2003
- Study completion
- Oct 2006 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BP >140/85
- 3 antihypertensive drugs (ACE/ARB + calcium channel blocker + thiazide diuretic)
Key exclusion criteria (7 listed)
- Pregnancy
- Breast Feeding
- Unstable heart failure
- Chronic Liver Disease
- Creatinine >120 mcmol/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardura XL 4 mg bd | Drug | – |
| Amiloride 5 mg bd | Drug | – |
| Furosemide 40 mg bd | Drug | – |
Primary outcome
Change in ECV; change in BP
Results and safety
The study was stopped early (reason given: Insufficient accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy WR Doulton, BSc MRCP principal investigator
SGUL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardura XL 4 mg bd, Amiloride 5 mg bd and Furosemide 40 mg bd in people with Hypertension, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient accrual rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ECV; change in BP. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.