Sympathetic Nervous System Modulation in Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00491387
Recruitment Status : Terminated (Adverse events reported with beta-blockers as primary therapy.)
First Posted : June 26, 2007
Results First Posted : April 19, 2011
Last Update Posted : February 7, 2018
Information provided by (Responsible Party):
Myron C. Gerson, University of Cincinnati

June 21, 2007
June 26, 2007
February 22, 2011
April 19, 2011
February 7, 2018
August 2007
January 2009   (Final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00491387 on Archive Site
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Sympathetic Nervous System Modulation in Hypertension
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.
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.
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Metoprolol Succinate
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:
  • Toprol XL
  • metoprolol XR
Experimental: metoprolol succinate
Subjects will undergo I-123 MIBG testing before and after sustained-release beta-adrenergic blockade.
Intervention: Drug: Metoprolol Succinate
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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January 2009
January 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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United States
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Plan to Share IPD: No
Myron C. Gerson, University of Cincinnati
University of Cincinnati
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Principal Investigator: Myron C Gerson, M.D. University of Cincinnati
University of Cincinnati
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP