Low-Renin HypertensionNCT00429897
Double Blind Crossover Comparison of Diuretics in the Young
A study testing Bendroflumethiazide 2.5mg - 5mg, Amiloride 20-40mg and Spironolactone 50-100mg in people with Low-Renin Hypertension, run by University of Cambridge at 1 site in United Kingdom.
Trial summary
The principle objective of the study is to determine whether low-renin (i.e. salt sensitive) hypertension at a young age is caused by the kidneys hanging onto too much salt as a result of an over active salt pump in the kidney. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Low-Renin Hypertension
- What is being tested?
- Bendroflumethiazide 2.5mg - 5mg, Amiloride 20-40mg and Spironolactone 50-100mg
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2006to Jul 2007
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-45
- male or female
- Hypertensive - 3 clinic SBP >=140mmHg; or 3 clinic DBP >=90mmHg; or ABPM or home BP >=130(SBP) or 85(DBP)
- 24hr Na+<160mmol/l
- EITHER {Plasma renin<=10mU/L (measured untreated, or whilst receiving only CCB+/-diuretic} + {Plasma renin <=40mU/L (measured on an ACEi or ARB, which approximately double s the plasma renin)} OR Plasma renin <5mU/L (measured untreated, or receiving any antihypertensive drug other than a beta-blocker
Who cannot join
- Documented history of gout
- Abnormal renal function (both elevated serum creatinine and reduced creatinine clearance
- SBP > 170mmHg or Diastolic >110mmHg despite treatment with permitted background treatment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Cambridge - Addenbrookes Hospital
Cambridge, CB2 2QQ
Morris J Brown, Proffessor, 01223 336743, mjb14@medschl.cam.uk
Sue Hood, RGN - sister
About this study
Official title: Double Blind Crossover Comparison od Diuretics in Young Patients With Low Renin Hypertension
The principle objective of the study is to determine whether low-renin (i.e. salt sensitive) hypertension at a young age is caused by the kidneys hanging onto too much salt as a result of an over active salt pump in the kidney.
The kidneys have four different salt pumps, and each is blocked by a different type of diuretic (salt losing tablet)If one out of the four is overactive, we would expect patients to respond much better to one diuretic than to the alternatives - rather than responding equally well to all available types of diuretic.
Read the detailed description
Studies suggest that patients with low renin hypertension respond better to diuretics than other hypertensive drug groups. The aim of the study is to rotate patients through the four main diuretic groups and see if it is possible to identify the most effective diuretic for this group, as measured by a >=10mgHg decrease in Systolic blood pressure in one specific group a compared to the others.
As most caucasians with Low renin hypertension are older (>55), presentation with this type of hypertension at a younger age suggests the presence of substantial genetic variation in order to cause the atypical presentation. It is hoped that by identifying the best diuretic for these patients we will also be able to identify:
- Whether the young low-renin hypertensives can be sub-classified according to their most effective diuretic;
- Whether this sub-classification helps us to identify the genes and mutations responsible, since these are to expected to be in the so-called sodium channels (i.e. salt pumps)which the kidneys use to prevent salt being excreted in the urine.
- Conditions
- Low-Renin Hypertension
- Being tested
- Bendroflumethiazide 2.5mg - 5mg, Amiloride 20-40mg, Spironolactone 50-100mg, Frusemide 20-40mg, Bendroflumethiazide 1.25-2.5mg/ Amiloride 10-20mg combined
- Keywords
- Hypertension, Low Renin
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bendroflumethiazide 2.5mg - 5mgDrug
Amiloride 20-40mgDrug
Spironolactone 50-100mgDrug
Frusemide 20-40mgDrug
Bendroflumethiazide 1.25-2.5mg/ Amiloride 10-20mg combinedDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in systolic blood pressure for subjects' best drug and second best drug.
Difference in plasma renin for subjects' best drug and second best drug.
Secondary outcomes (1)
Predictions of best drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startAug 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-Renin 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
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Investigators
- Morris J Brown, Proffessor, Principal investigator, Cambridge University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429897
- Sponsor's protocol ID
- 1.0
- Status last verified
- Jan 2007
- First submitted
- 31 Jan 2007
- Last updated
- 1 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Crossover Comparison od Diuretics in Young Patients With Low Renin Hypertension
- ClinicalTrials.gov ID
- NCT00429897
- Acronym / sponsor ID
- 1.0
- Conditions
- Low-Renin Hypertension
- Keywords
- Hypertension, Low Renin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Aug 2006
- Study completion
- Jul 2007
- First posted
- 1 Feb 2007 (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 principle objective of the study is to determine whether low-renin (i.e. salt sensitive) hypertension at a young age is caused by the kidneys hanging onto too much salt as a result of an over active salt pump in the kidney.
The kidneys have four different salt pumps, and each is blocked by a different type of diuretic (salt losing tablet)If one out of the four is overactive, we would expect patients to respond much better to one diuretic than to the alternatives - rather than responding equally well to all available types of diuretic.
Detailed description
Studies suggest that patients with low renin hypertension respond better to diuretics than other hypertensive drug groups. The aim of the study is to rotate patients through the four main diuretic groups and see if it is possible to identify the most effective diuretic for this group, as measured by a >=10mgHg decrease in Systolic blood pressure in one specific group a compared to the others.
As most caucasians with Low renin hypertension are older (>55), presentation with this type of hypertension at a younger age suggests the presence of substantial genetic variation in order to cause the atypical presentation. It is hoped that by identifying the best diuretic for these patients we will also be able to identify:
- Whether the young low-renin hypertensives can be sub-classified according to their most effective diuretic;
- Whether this sub-classification helps us to identify the genes and mutations responsible, since these are to expected to be in the so-called sodium channels (i.e. salt pumps)which the kidneys use to prevent salt being excreted in the urine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-45
- male or female
- Hypertensive - 3 clinic SBP >=140mmHg; or 3 clinic DBP >=90mmHg; or ABPM or home BP >=130(SBP) or 85(DBP)
- 24hr Na+<160mmol/l
- EITHER {Plasma renin<=10mU/L (measured untreated, or whilst receiving only CCB+/-diuretic} + {Plasma renin <=40mU/L (measured on an ACEi or ARB, which approximately double s the plasma renin)} OR Plasma renin <5mU/L (measured untreated, or receiving any antihypertensive drug other than a beta-blocker
Key exclusion criteria (3 listed)
- Documented history of gout
- Abnormal renal function (both elevated serum creatinine and reduced creatinine clearance
- SBP > 170mmHg or Diastolic >110mmHg despite treatment with permitted background treatment
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 |
|---|---|---|
| Bendroflumethiazide 2.5mg - 5mg | Drug | – |
| Amiloride 20-40mg | Drug | – |
| Spironolactone 50-100mg | Drug | – |
| Frusemide 20-40mg | Drug | – |
| Bendroflumethiazide 1.25-2.5mg/ Amiloride 10-20mg combined | Drug | – |
Primary outcome
Difference in systolic blood pressure for subjects' best drug and second best drug.
Difference in plasma renin for subjects' best drug and second best drug.
1 secondary outcome
Predictions of best drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2007.
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.
Morris J Brown, Proffessor principal investigator
Cambridge University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bendroflumethiazide 2.5mg - 5mg, Amiloride 20-40mg and Spironolactone 50-100mg in people with Low-Renin Hypertension, run by University of Cambridge 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Feb 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morris J Brown, Professor (01223 336743, mjb14@medschl.cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in systolic blood pressure for subjects' best drug and second best drug.. The study lists 2 primary outcomes in all. 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 1 Feb 2007.