Sympathetic Nervous System Modulation in Hypertension
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Hypertension |
| Intervention | Drug: Sustained release metoprolol |
| Phase | Phase 4 |
| Sponsor | University of Cincinnati |
| Responsible Party | University of Cincinnati |
| ClinicalTrials.gov Identifier | NCT00491387 |
| First Received | June 21, 2007 |
| Last Updated | July 16, 2012 |
| Last verified | July 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 21, 2007 |
|---|---|
| Last Updated Date | July 16, 2012 |
| Start Date | August 2007 |
| Estimated Primary Completion Date | January 2009 |
| Current Primary Outcome Measures | Improved Sympathetic Cardiac Innervation. [Time Frame: 6 months] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Sympathetic Nervous System Modulation in Hypertension |
|---|---|
| Official Title | Sympathetic Nervous System Modulation in Hypertension by Beta-adrenergic Blockade |
| Brief 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. 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 | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Hypertension |
| Intervention | Drug: Sustained release metoprolol 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. Other Names:
|
| Study Arm (s) | Experimental: Beta-adrenergic blockade |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 24 |
| Estimated Completion Date | January 2009 |
| Estimated Primary Completion Date | January 2009 |
| Eligibility Criteria | Inclusion Criteria: - Essential hypertension with blood pressure less than 140/90 on either an ACE inhibitor or angiotensin receptor blocker Exclusion Criteria: - 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 - 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. |
| Gender | Both |
| Ages | 20 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00491387 |
|---|---|
| Other Study ID Numbers | #07-01-12-01 |
| Has Data Monitoring Committee | No |
| Information Provided By | University of Cincinnati |
| Study Sponsor | University of Cincinnati |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Myron C Gerson, M.D. University of Cincinnati |
| Verification Date | July 2012 |