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

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Metoprolol Succinate Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sympathetic Nervous System Modulation in Hypertension by Beta-adrenergic Blockade
Study Start Date : August 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: metoprolol succinate
Subjects will undergo I-123 MIBG testing before and after sustained-release beta-adrenergic blockade.
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

Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00491387

Sponsors and Collaborators
University of Cincinnati
Principal Investigator: Myron C Gerson, M.D. University of Cincinnati

Responsible Party: Myron C. Gerson, Professor, University of Cincinnati Identifier: NCT00491387     History of Changes
Other Study ID Numbers: #07-01-12-01
First Posted: June 26, 2007    Key Record Dates
Results First Posted: April 19, 2011
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Myron C. Gerson, University of Cincinnati:
sympathetic nervous system

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action