Trial Outcomes & Findings for Effect of GLP - 1 (7-36 Amide) on Myocardial Function Following Coronary Artery Bypass (CABG) Surgery (NCT NCT00966654)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

2 years

Results posted on

2017-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	GLP-1 GLP-1 (7-36) amide GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours. OR Placebo (saline)
Overall Study STARTED	12
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	GLP-1 GLP-1 (7-36) amide GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours. OR Placebo (saline)
Overall Study Study was terminated,PI left institution	12

Baseline Characteristics

Effect of GLP - 1 (7-36 Amide) on Myocardial Function Following Coronary Artery Bypass (CABG) Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=12 Participants GLP-1 (7-36) amide GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours.
Age, Customized Age, years (18-75)	12 participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: The raw study data is not available for this study. The study was terminated early due to the P.I.'s noncompliance with Johns Hopkins University School of Medicine Institutional Review Board Protocol and he has since left the institution. Significant efforts have been made to locate data, but it is unfortunately unavailable.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours

Population: The raw study data is not available for this study. The study was terminated early due to the P.I.'s noncompliance with JHU IRB Protocol and he has since left the institution. Significant efforts have been made to locate data, but it is unfortunately unavailable.

Outcome measures

Outcome data not reported

Adverse Events

GLP-1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline

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

Johns Hopkins University Clinical Trials Program

Johns Hopkins University School of Medicine

Phone: 410-550-6484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place