GLP-1 and hyperoxia for organ protection in heart surgery

Phase 1

• Conditions: We investigate the efficacy of commercially available GLP-1 analog for reducing organ damage in patients undergoing heart surgery (i.e. coronary artery bypass grafting and/or aortic valve replacement).In addition we investigate the efficacy of restrictive versus liberal oxygenation (i.e. FiO2 50% versus FiO2 100%) for reducing organ damage during weaning after heart surgery. The study is a two-by-two factorial designed randomized clinical trial.; MedDRA version: 20.0Level: LLTClassification code 10008937Term: Chronic ischemic heart disease, unspecifiedSystem Organ Class: 100000011627; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-003050-41-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-20
• Last Update Posted: 28 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1)Before any study-specific procedure, including assessments for screening, the appropriate written informed consent must be obtained
2)= 18 years of age at the time of signing informed consent
3)IHD requiring CABG (multi-vessel coronary artery disease or coronary anatomy not suitable for percutaneous coronary intervention) and/or Aortic Valve Disease scheduled for AVR, irrespective of other concomitant valve surgery.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 900

Exclusion Criteria

1)Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism or history of or active acute pancreatitis.
2)Acute (i.e. off hours, within hours surgery), Sub-acute surgery (i.e. the following days are eligible).
3)Known allergy towards Exenatide/Byetta or albumin (vehicle).
4)On the urgent waiting list for a heart transplant (UNOS category 1A or 1B, or equivalent). Patients on the non-urgent waiting list for a heart transplant (UNOS category 2 or 7, or equivalent) are eligible for inclusion in the study.
5)Recipient of any major organ transplant (e.g. lung, liver, heart)
6)Receiving or has received cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 month before randomization or clinical evidence of current malignancy, with the following exceptions: basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable localized disease, with a life expectancy of > 2.5 years in the opinion of the investigator)
7)Currently enrolled in, or at least 30 days not yet elapsed since ending participation in other investigational drug trial(s) for the treatment of Diabetes or malignant Obesity investigating the use of GLP-1 agonists or receiving other investigational agent(s). Concomitant participation in other non-pharmacological trials is not an exclusion criterion.
8)Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report.
9)Pregnant, based on investigator evaluation (e.g., positive human chorionic gonadotropin test) or currently breast feeding.
10)Any condition (e.g., psychiatric illness) or situation that, in the investigator’s opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject’s participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified