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Sympathetic Nervous System Modulation in Hypertension

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ClinicalTrials.gov Identifier: NCT00491387
Recruitment Status : Terminated (Publications appeared suggesting increased mortality using beta-blockers as primary therapy for hypertension.)
First Posted : June 26, 2007
Results First Posted : April 19, 2011
Last Update Posted : July 19, 2012
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hypertension
Intervention: Drug: Sustained release metoprolol

  Participant Flow

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
No text entered.

Reporting Groups
Group 1 No text entered.

Participant Flow:   Overall Study
    Group 1
Study Enrollment   24 

  Baseline Characteristics

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
Group 1 No text entered.

Baseline Measures
   Group 1 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   21 
>=65 years   3 
[Units: Years]
Mean (Standard Deviation)
 48  (11) 
[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

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

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

Responsible Party: Myron C. Gerson, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00491387     History of Changes
Other Study ID Numbers: #07-01-12-01
First Submitted: June 21, 2007
First Posted: June 26, 2007
Results First Submitted: February 22, 2011
Results First Posted: April 19, 2011
Last Update Posted: July 19, 2012