HypertensionNCT00518479
Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression
A study testing Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD and Valsartan 160mg OD; Moxonidine 400mcg OD in people with Hypertension and Left Ventricular Hypertrophy, run by University of Leeds at 1 site in United Kingdom.
Trial summary
Uncontrolled high blood pressure can cause heart muscle 'thickening', and this increases the likelihood of complications and death. The high blood pressure explains some but not all of this increase in heart size. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Hypertension, Left Ventricular Hypertrophy
- What is being tested?
- Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD and Valsartan 160mg OD; Moxonidine 400mcg OD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2003to Apr 2004
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recently diagnosed essential hypertension (within 6 months).
- Age 25 to 80 years; Weight < 100kg.
- Sinus rhythm without significant ventricular or atrial ectopy.
Who cannot join
- Current angiotensin II receptor antagonist or ACE Inhibitor treatment.
- Contra-indication to any of the protocol anti-hypertensive agents.
- Angina requiring treatment with a Beta blocker or calcium antagonist
- Any disease affecting the autonomic nervous system e.g. congestive cardiac failure, diabetes, neurological disease, malignancy, pregnancy.
- Contraindication to MRI (pacemaker, intra-orbital debris, intra-auricular implants, intra-cranial clips, history of claustrophobia, inability to lie supine for 15 minutes etc).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospital NHS Trust
Leeds, Wesst Yorkshire, LS1 3EX
About this study
Uncontrolled high blood pressure can cause heart muscle 'thickening', and this increases the likelihood of complications and death. The high blood pressure explains some but not all of this increase in heart size. This study will investigate the other causes, and will measure the heart muscle 'thickness' very accurately using the latest and most accurate technique called cardiac magnetic resonance imaging (MRI). The best way to treat this heart thickening remains to be determined. We hope to be able to show that by specifically targeting the cause of heart muscle thickening we can reduce its occurrence more effectively than by other standard means of blood pressure treatment
- Conditions
- Hypertension, Left Ventricular Hypertrophy
- Being tested
- Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD, Valsartan 160mg OD; Moxonidine 400mcg OD
- Keywords
- Hypertension, Left Ventricular Hypertrophy
- Medical subject headings
- Hypertension, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bendroflumethiazide 2.5mg OD; Amlodipine 10mg ODDrug
Valsartan 160mg OD; Moxonidine 400mcg ODDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Neurohormonal stimulatory arm Receives: Drug: Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD |
| 2 | Experimental | Neurohormonal inhibitory arm Receives: Drug: Valsartan 160mg OD; Moxonidine 400mcg OD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is decrease in LV mass as assessed by cardiac MRI compared between the two treatment groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2007 (estimated)
- Study startSep 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Principal investigator, Dr JP Greenwood, University of Leeds
- Investigators
- John P Greenwood, MBChB, PhD, Principal investigator, Leeds University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518479
- Sponsor's protocol ID
- PG/03/001
- Status last verified
- Aug 2012
- First submitted
- 17 Aug 2007
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Burns J, Sivananthan MU, Ball SG, Mackintosh AF, Mary DA, Greenwood JP. Relationship between central sympathetic drive and magnetic resonance imaging-determined left ventricular mass in essential hypertension. Circulation. 2007 Apr 17;115(15):1999-2005. doi: 10.1161/CIRCULATIONAHA.106.668863. Epub 2007 Mar 26.
PubMed 17389264
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression
- ClinicalTrials.gov ID
- NCT00518479
- Acronym / sponsor ID
- PG/03/001
- Conditions
- Hypertension, Left Ventricular Hypertrophy
- Keywords
- Hypertension, Left Ventricular Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Study start
- Sep 2003
- Study completion
- Apr 2004 (actual)
- First posted
- 20 Aug 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.
Uncontrolled high blood pressure can cause heart muscle 'thickening', and this increases the likelihood of complications and death. The high blood pressure explains some but not all of this increase in heart size. This study will investigate the other causes, and will measure the heart muscle 'thickness' very accurately using the latest and most accurate technique called cardiac magnetic resonance imaging (MRI). The best way to treat this heart thickening remains to be determined. We hope to be able to show that by specifically targeting the cause of heart muscle thickening we can reduce its occurrence more effectively than by other standard means of blood pressure treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bendroflumethiazide 2.5mg OD; Amlodipine 10mg ODNeurohormonal stimulatory arm |
| 2 | Experimental | Drug: Valsartan 160mg OD; Moxonidine 400mcg ODNeurohormonal inhibitory arm |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recently diagnosed essential hypertension (within 6 months).
- Age 25 to 80 years; Weight < 100kg.
- Sinus rhythm without significant ventricular or atrial ectopy.
Key exclusion criteria (5 listed)
- Current angiotensin II receptor antagonist or ACE Inhibitor treatment.
- Contra-indication to any of the protocol anti-hypertensive agents.
- Angina requiring treatment with a Beta blocker or calcium antagonist
- Any disease affecting the autonomic nervous system e.g. congestive cardiac failure, diabetes, neurological disease, malignancy, pregnancy.
- Contraindication to MRI (pacemaker, intra-orbital debris, intra-auricular implants, intra-cranial clips, history of claustrophobia, inability to lie supine for 15 minutes etc).
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 OD; Amlodipine 10mg OD | Drug | 1 |
| Valsartan 160mg OD; Moxonidine 400mcg OD | Drug | 2 |
Primary outcome
The primary outcome measure is decrease in LV mass as assessed by cardiac MRI compared between the two treatment groups.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
- Results publication: PubMed 17389264Burns J, Sivananthan MU, Ball SG, Mackintosh AF, Mary DA, Greenwood JP. Relationship between central sympathetic drive and magnetic resonance imaging-determined left ventricular mass in essential hypertension. Circulation. 2007 Apr 17;115(15):1999-2005. doi: 10.1161/CIRCULATIONAHA.106.668863. Epub 2007 Mar 26.
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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.
John P Greenwood, MBChB, PhD principal investigator
Leeds 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 OD; Amlodipine 10mg OD and Valsartan 160mg OD; Moxonidine 400mcg OD in people with Hypertension and Left Ventricular Hypertrophy, run by University of Leeds 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 16 Aug 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome measure is decrease in LV mass as assessed by cardiac MRI compared between the two treatment groups. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00518479, which also lists 1 linked publication.
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 16 Aug 2012; AzTrials last refreshed its copy on 6 Nov 2026.