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 a beta-adrenergic receptor blocker will provide additional blockade of the sympathetic nervous system, thereby further improving left ventricular filling and blood pressure control.

Study Type: Interventional

Study Design: Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: Sustained release metoprolol
  • Once daily, dose titrated to reduce heart rate by 20% or to less than 65 beats per minute.

Primary Measures

• Improved left ventricular diastolic function
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Improved sympathetic cardiac innervation.
  • Time Frame: 6 months
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Cincinnati

Overall Clinical Trial Officials and Contacts

Myron C Gerson, M.D. Principal Investigator University of Cincinnati  

Overall Contact: Myron C Gerson, MD 513-558-3074 myron.gerson@uc.edu

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00491387

Study ID Number: #07-01-12-01

ClinicalTrials.gov Identifier: NCT00491387

Health Authority: United States: Food and Drug Administration