Sympathetic Nervous System Modulation in Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00491387
Recruitment Status : Terminated (Adverse events reported with beta-blockers as primary therapy.)
First Posted : June 26, 2007
Results First Posted : April 19, 2011
Last Update Posted : February 7, 2018
Information provided by (Responsible Party):
Myron C. Gerson, University of Cincinnati

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hypertension
Intervention: Drug: Metoprolol Succinate

  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 Treated with metoprolol succinate

Participant Flow:   Overall Study
    Group 1
Study Enrollment   24 
study terminated                20 

  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
Metoprolol Succinate will receive I-123 MIBG innervation imaging before and after metoprolol succinate

Baseline Measures
   Metoprolol Succinate 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      21  87.5% 
>=65 years      3  12.5% 
[Units: Years]
Mean (Standard Deviation)
 48  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      14  58.3% 
Male      10  41.7% 
Region of Enrollment 
[Units: Participants]
United States   24 

  Outcome Measures

1.  Primary:   Improvement in Sympathetic Cardiac Innervation as Measured by I-123 MIBG Heart - Mediastinum Ratio   [ Time Frame: january 2018 ]

  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

Responsible Party: Myron C. Gerson, University of Cincinnati 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: February 7, 2018