Trial Outcomes & Findings for Sympathetic Nervous System Modulation in Hypertension (NCT NCT00491387)

Results Overview

24 subjects had baseline I-123 MIBG imaging. No subject completed all aspects of the protocol. The study was closed due to unfavorable publication related to metoprolol treatment for hypertension.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

january 2018

Results posted on

2018-02-07

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Group 1 Treated with metoprolol succinate
Overall Study STARTED	24
Overall Study Study Enrollment	24
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 Treated with metoprolol succinate
Overall Study study terminated	20

Baseline Characteristics

Sympathetic Nervous System Modulation in Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metoprolol Succinate n=24 Participants will receive I-123 MIBG innervation imaging before and after metoprolol succinate
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	48 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: january 2018

24 subjects had baseline I-123 MIBG imaging. No subject completed all aspects of the protocol. The study was closed due to unfavorable publication related to metoprolol treatment for hypertension.

Outcome measures

Outcome data not reported

Adverse Events

Metoprolol Succinate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Myron Gerson MD

University of Cincinnati

Phone: 5135583974

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place