Sympathetic Nervous System Modulation in Hypertension

NCT ID: NCT00491387

Last Updated: 2018-02-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-01-31

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

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.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

metoprolol succinate

Subjects will undergo I-123 MIBG testing before and after sustained-release beta-adrenergic blockade.

Group Type: EXPERIMENTAL

Metoprolol Succinate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Toprol XL; metoprolol XR

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Myron C. Gerson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Myron C Gerson, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Other Identifiers

#07-01-12-01

Identifier Type: -

Identifier Source: org_study_id