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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
Results First Received: February 22, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Intervention: Drug: Sustained release metoprolol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was stopped early due to concerns resulting from a publication reporting an increased in mortality in cardiac deaths in patients treated with beta-blockers as the primary drug for hypertension. Although no adverse reactions were observed in the present study, it was decided by the PI that beta-blockers could not ethically be continued.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not applicable.

Reporting Groups
  Description
Group 1 No text entered.

Participant Flow:   Overall Study
    Group 1  
STARTED     24  
Study Enrollment     24  
COMPLETED     24  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1 No text entered.

Baseline Measures
    Group 1  
Number of Participants  
[units: participants]
  24  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     21  
>=65 years     3  
Age  
[units: years]
Mean ± Standard Deviation
  48  ± 11  
Gender  
[units: participants]
 
Female     14  
Male     10  
Region of Enrollment  
[units: participants]
 
United States     24  



  Outcome Measures

1.  Primary:   Improved Sympathetic Cardiac Innervation.   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination due to a publication in the literature suggesting potential increased cardiac mortality in hypertensive patients treated primarily with beta blockers. Did not feel that continued treatment in volunteer subjects could be justified.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Myron Gerson MD
Organization: University of Cincinnati
phone: 5135583974
e-mail: myron.gerson@uc.edu


No publications provided


Responsible Party: Myron C. Gerson, University of Cincinnati
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: July 16, 2012
Health Authority: United States: Food and Drug Administration