Sympathetic Nervous System Modulation in Hypertension

This study has been terminated.

( Publications appeared suggesting increased mortality using beta-blockers as primary therapy for hypertension. )

First Received on June 21, 2007. Last Updated on April 21, 2011 History of Changes

Sponsor:	University of Cincinnati
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00491387

Purpose

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	Intervention	Phase
Hypertension	Drug: Sustained release metoprolol	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Sympathetic Nervous System Modulation in Hypertension by Beta-adrenergic Blockade

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Metoprolol Metoprolol Tartrate Metoprolol succinate Metoprolol fumarate

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

Improved Sympathetic Cardiac Innervation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	August 2007
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Beta-adrenergic blockade	Drug: Sustained release metoprolol 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

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491387

Sponsors and Collaborators

University of Cincinnati

Investigators

Principal Investigator:

Myron C Gerson, M.D.

University of Cincinnati

More Information

No publications provided

Responsible Party:	Tipton H. Ford, University Internal Medicine Associates
ClinicalTrials.gov Identifier:	NCT00491387 History of Changes
Other Study ID Numbers:	#07-01-12-01
Study First Received:	June 21, 2007
Results First Received:	February 22, 2011
Last Updated:	April 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Cincinnati:

hypertension
sympathetic nervous system

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Adrenergic Agents
Metoprolol
Metoprolol succinate
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists

ClinicalTrials.gov processed this record on February 09, 2012