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.

Study Overview

• Status: Terminated
• Conditions: Hypertension
• Intervention / Treatment: Drug: Metoprolol Succinate

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
• Enrollment (Actual): 24
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	january 2018

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Myron C Gerson, M.D., University of Cincinnati

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: June 21, 2007
• First Submitted That Met QC Criteria: June 22, 2007
• First Posted (Estimate): June 26, 2007

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 2, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: hypertension; sympathetic nervous system
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Metoprolol
• Other Study ID Numbers: #07-01-12-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO