Sympathetic Nervous System Modulation in Hypertension

This study has been terminated.

( Publications appeared suggesting increased mortality using beta-blockers as primary therapy for hypertension. )

Study NCT00491387 Information provided by University of Cincinnati

First Received on June 21, 2007. Last Updated on April 21, 2011 History of Changes

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

Hide 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
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

Hide Baseline Characteristics

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 ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide 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.

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.

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:	Tipton H. Ford, University Internal Medicine Associates
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:	April 21, 2011
Health Authority:	United States: Food and Drug Administration