This trial is active, not recruiting.

Condition cabg
Treatments placebo, glp-1 (7-36) amide
Phase phase 2
Sponsor Johns Hopkins University
Start date September 2008
End date August 2011
Trial size 48 participants
Trial identifier NCT00966654, NA_00013802


This research is being done to see if giving a hormone called GLP-1 can improve heart function and reduce length of stay in the Cardiac Surgical Intensive Care Unit (CSICU) in people who have non-emergent coronary artery bypass graft (CABG) surgery.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Placebo Comparator)
placebo Saline
1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours.
(Active Comparator)
GLP-1 (7-36) amide
glp-1 (7-36) amide GLP-1
1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours.

Primary Outcomes

Left ventricular systolic function, Left ventricular diastolic function and Hemodynamic parameters when available: PCWP, CO, SVR, HR, MAP
time frame: 2 years

Secondary Outcomes

Insulin infusion requirements, Frequency of hypoglycemic events, Length of stay in ICU setting and Inotropic requirements at each 12 hour period after arrival to the ICU and during infusion
time frame: 72 hours

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Males and Females age > 18 years of age - Able to consent - Scheduled for non-emergent coronary artery bypass graft (CABG) - Have an ejection fraction < 35% - Ischemic patients with LVD who need a valve procedure with their CABG Exclusion Criteria: - Emergency coronary artery bypass graft surgery - Patients with an ejection fraction > 35% - Repeat or redo CABG patients - Patients with a history of pancreatitis - Pregnant or lactating females

Additional Information

Official title Effect of GLP - 1 (7-36 Amide) on Myocardial Function Following Coronary Artery Bypass Surgery
Principal investigator Dariush Elahi, PhD
Description After CABG surgery, a condition known as hyperglycemia or high blood sugar often occurs even in patients who have never been diagnosed with diabetes. This high blood sugar can lead to complications after surgery such as infections at the site of the incision. Additionally, if there is any cardiac muscle injury either prior to or during surgery, the injured cardiac muscle can not use glucose (the body's fuel and energy source) as well as it did prior to the injury. This reduced ability to use glucose slows the cardiac muscles ability to repair itself and provide the normal pumping force and function needed to circulate the blood throughout the body. This inability to repair itself and/or provide the normal pumping force and function can make it difficult for the patient as well as increase the length of stay required in the CSICU. GLP-1 has the ability to lower blood sugar and help cells use glucose for fuel and energy but when the blood sugar becomes low its glucose lowering ability decreases. In this study, we want to see we want to see if GLP-1 may help keep the blood sugar within normal limits and reduce or eliminate the need for insulin. We will also see whether it will help the heart recover more quickly.
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Johns Hopkins University.