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

NCT00966654 | Terminated Phase 2 Results

• 1 other identifier: NA_00013802
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CABG

Keywords

CABG; Cardiac Surgical Patient

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Systolic Function: Pulmonary Capillary Wedge Pressure

  2 years

Secondary Outcomes (1)

• Insulin Infusion Requirements

  72 hours

Study Arms (2)

Saline

PLACEBO COMPARATOR

Saline

Drug: Placebo

GLP-1

ACTIVE COMPARATOR

GLP-1 (7-36) amide

Drug: GLP-1 (7-36) amide

Interventions

Placebo DRUG

1.5 pmol/kg/min (5 ng/kg/min) saline infused continuously over 72 hours.

Also known as: Saline

Saline

GLP-1 (7-36) amide DRUG

1.5 pmol/kg/min (5 ng/kg/min) GLP-1 infused continuously over 72 hours.

Also known as: GLP-1

GLP-1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Left Ventricular Dysfunction (LVD) who need a valve procedure with their CABG

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Interventions

Sodium Chloride; glucagon-like peptide 1 (7-36)amide; Glucagon-Like Peptide 1

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Johns Hopkins University Clinical Trials Program
• Organization: Johns Hopkins University School of Medicine

registerclinicaltrials@jhmi.edu

410-550-6484

Study Officials

• Dariush Elahi, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: September 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2012
• Last Updated: July 12, 2017
• Results First Posted: July 12, 2017

Record last verified: 2017-06

Locations

US (1)