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Sympathetic Nervous System Modulation in Hypertension

This study has been terminated.
(Publications appeared suggesting increased mortality using beta-blockers as primary therapy for hypertension.)
Sponsor:
Information provided by (Responsible Party):
Myron C. Gerson, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00491387
First received: June 21, 2007
Last updated: July 16, 2012
Last verified: July 2012

June 21, 2007
July 16, 2012
August 2007
January 2009   (final data collection date for primary outcome measure)
Improved Sympathetic Cardiac Innervation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00491387 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
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
Experimental: Beta-adrenergic blockade
Intervention: Drug: Sustained release metoprolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
January 2009
January 2009   (final data collection date for primary outcome measure)

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.
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00491387
#07-01-12-01
No
Myron C. Gerson, University of Cincinnati
University of Cincinnati
Not Provided
Principal Investigator: Myron C Gerson, M.D. University of Cincinnati
University of Cincinnati
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP