Sympathetic Nervous System Modulation in Hypertension
Information source: University of Cincinnati
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Sustained release metoprolol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Cincinnati Official(s) and/or principal investigator(s):
Myron C Gerson, M.D., Principal Investigator, Affiliation: University of Cincinnati
Overall contact:
Myron C Gerson, MD, Phone: 513-558-3074, Email: myron.gerson@uc.edu
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.
Clinical Details
Official title: Sympathetic Nervous System Modulation in Hypertension by Beta-Adrenergic Blockade
Study design: Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary outcome: Improved left ventricular diastolic function
Secondary outcome: Improved sympathetic cardiac innervation.
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Myron C Gerson, MD, Phone: 513-558-3074, Email: myron.gerson@uc.edu
University of Cincinnati, Cincinnati, Ohio 45267, United States; Recruiting
Cindy Werner, RN, Phone: 513-558-4721, Email: cindy.werner@uc.edu
Mohamed A Effat, MD, Principal Investigator
Additional Information
Starting date: August 2007
Last updated: December 4, 2008
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