HypertensionPhase 4NCT00491387
Sympathetic Nervous System Modulation in Hypertension
A Phase 4 study testing Metoprolol Succinate in people with Hypertension, run by University of Cincinnati.
Trial summary
This is a study of patients with high blood pressure who are already treated with an angiotensin converting enzyme inhibitor or receptor blocker and have achieved good or fair blood pressure control. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Metoprolol Succinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jan 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Essential hypertension with blood pressure less than 140/90 on either an ACE inhibitor or angiotensin receptor blocker
Who cannot join
- Known valvular heart disease of more than mild severity
- Known coronary artery disease defined by an angiographic coronary artery stenosis greater than or equal to 50% luminal diameter narrowing, acute or previous myocardial infarction, or previous coronary revascularization
- Known non-ischemic cardiomyopathy with left ventricular ejection fraction less than 50%
- Atrial fibrillation
- Current treatment with a β-adrenergic blocking drug or a calcium channel blocker
- Current treatment with a psychoactive or other drug known to alter 123I-MIBG uptake
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- Participation in another research study within the prior 30 days
- A life-limiting disease process that is likely to preclude completion of study participation
- Pregnancy or breast feeding
- Inability or unwillingness to provide informed consent
- Baseline resting heart rate less than 65 beats per minute
- Diabetes
- Iodine allergy
- Unwilling to sign informed consent.
About this study
Official title: Sympathetic Nervous System Modulation in Hypertension by Beta-adrenergic Blockade
This is a study of patients with high blood pressure who are already treated with an angiotensin converting enzyme inhibitor or receptor blocker and have achieved good or fair blood pressure control. The hypothesis is that addition of the beta-adrenergic receptor blocker, sustained-release metoprolol, will provide additional blockade of the sympathetic nervous system, thereby further improving left ventricular filling and blood pressure control.
Read the detailed description
Patients were to receive sympathetic cardiac innervation testing with I-123 MIBG at baseline and again after receiving a titrate dose of beta-blocker. Data were to be assesses by repeated measures testing.
- Conditions
- Hypertension
- Being tested
- Metoprolol Succinate
- Keywords
- hypertension, sympathetic nervous system
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoprolol SuccinateDrug
Also called Toprol XL, metoprolol XR
Once daily, oral, 12.5 mg to 200 mg, dose titrated to reduce heart rate by 20% or to less than 65 beats per minute.
| Study group | Role | What they receive |
|---|---|---|
| metoprolol succinate | Experimental | Subjects will undergo I-123 MIBG testing before and after sustained-release beta-adrenergic blockade. Receives: Drug: Metoprolol Succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Sympathetic Cardiac Innervation as Measured by I-123 MIBG Heart - Mediastinum Ratio
24 subjects had baseline I-123 MIBG imaging. No subject completed all aspects of the protocol. The study was closed due to unfavorable publication related to metoprolol treatment for hypertension.
Measured: january 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startAug 2007
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Adverse events reported with beta-blockers as primary therapy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myron C. Gerson, University of Cincinnati
- Investigators
- Myron C Gerson, M.D., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491387
- Sponsor's protocol ID
- #07-01-12-01
- Status last verified
- Feb 2018
- First submitted
- 21 Jun 2007
- Last updated
- 7 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathetic Nervous System Modulation in Hypertension by Beta-adrenergic Blockade
- ClinicalTrials.gov ID
- NCT00491387
- Acronym / sponsor ID
- #07-01-12-01
- Conditions
- Hypertension
- Keywords
- hypertension, sympathetic nervous system
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adverse events reported with beta-blockers as primary therapy.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 26 Jun 2007 (estimated)
- Results
- Posted 19 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of patients with high blood pressure who are already treated with an angiotensin converting enzyme inhibitor or receptor blocker and have achieved good or fair blood pressure control. The hypothesis is that addition of the beta-adrenergic receptor blocker, sustained-release metoprolol, will provide additional blockade of the sympathetic nervous system, thereby further improving left ventricular filling and blood pressure control.
Detailed description
Patients were to receive sympathetic cardiac innervation testing with I-123 MIBG at baseline and again after receiving a titrate dose of beta-blocker. Data were to be assesses by repeated measures testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metoprolol succinate | Experimental | Drug: Metoprolol SuccinateSubjects will undergo I-123 MIBG testing before and after sustained-release beta-adrenergic blockade. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Essential hypertension with blood pressure less than 140/90 on either an ACE inhibitor or angiotensin receptor blocker
Key exclusion criteria (14 listed)
- Known valvular heart disease of more than mild severity
- Known coronary artery disease defined by an angiographic coronary artery stenosis greater than or equal to 50% luminal diameter narrowing, acute or previous myocardial infarction, or previous coronary revascularization
- Known non-ischemic cardiomyopathy with left ventricular ejection fraction less than 50%
- Atrial fibrillation
- Current treatment with a β-adrenergic blocking drug or a calcium channel blocker
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 |
|---|---|---|
| Metoprolol SuccinateAlso: Toprol XL, metoprolol XROnce daily, oral, 12.5 mg to 200 mg, dose titrated to reduce heart rate by 20% or to less than 65 beats per minute. | Drug | metoprolol succinate |
Primary outcome
Improvement in Sympathetic Cardiac Innervation as Measured by I-123 MIBG Heart - Mediastinum Ratio
Time frame: january 2018
24 subjects had baseline I-123 MIBG imaging. No subject completed all aspects of the protocol. The study was closed due to unfavorable publication related to metoprolol treatment for hypertension.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Myron C Gerson, M.D. principal investigator
University of Cincinnati
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoprolol Succinate in people with Hypertension, run by University of Cincinnati.
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 1 inclusion and 14 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 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Improvement in Sympathetic Cardiac Innervation as Measured by I-123 MIBG Heart - Mediastinum Ratio (time frame: january 2018). 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 7 Feb 2018.