Trial Outcomes & Findings for Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy (NCT NCT01048125)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

2 years

Results posted on

2016-11-23

2 participants were consented, but due to difficulty in recruitment and resource restraints the study did not progress as expected and was closed.

Participant milestones
Measure	Study Group Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation	Control Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation Sympathetic Nerve Activity: Resting Sympathetic Nerve Activity Mental Stress Test (Color Word Test): A printed word will be shown to the subject, displayed in a color different from the color it actually names. The subject will be asked to say the color that the word is printed in as quickly as possible. For example if the word "green" is written in blue ink, they will say "blue." This mental stress procedure will be used to cause brief changes in heart rate and blood pressure. The Modified Oxford Technique for Baroreflex Sensitivity: Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy

Baseline characteristics by cohort
Measure	Study Group Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation	Control Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation	Total Total of all reporting groups
Age, Categorical <=18 years	—	—	0 n=27 Participants
Age, Categorical Between 18 and 65 years	—	—	0 n=27 Participants
Age, Categorical >=65 years	—	—	0 n=27 Participants
Gender Female	—	—	0 n=27 Participants
Gender Male	—	—	0 n=27 Participants
Region of Enrollment United States	—	—	0 n=27 Participants

Timeframe: 2 years

Population: Due to difficulty in recruitment and resource restraints the study did not progress as expected and was closed.

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Missouri-Columbia

Phone: 573/882-2296