GLP-1 and Hyperoxia for Organ Protection in Heart Surgery (NCT02673931) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
GLP-1 and Hyperoxia for Organ Protection in Heart Surgery
Denmark1,400 participantsStarted 2016-02
Plain-language summary
Patients undergoing open heart surgery are at risk of suffering damage to the heart, brain and kidneys.
This study is designed as a 2-by-2 randomized clinical trial with the purpose of investigating the organ protective effects of the glucagon-like-peptide-1 (GLP-1) agonist Exenatide versus placebo and restrictive versus liberal oxygenation during weaning from cardio-pulmonary bypass.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Before any study-specific procedure, including assessments for screening, the appropriate written informed consent must be obtained.
* ≥ 18 years of age at the time of signing informed consent.
* Ischemic heart disease requiring coronary artery bypass grafting (multi-vessel coronary artery disease or coronary anatomy not suitable for percutaneous coronary intervention) and/or aortic valve disease scheduled for aortic valve replacement, irrespective of other concomitant valve surgery.
Exclusion Criteria:
* Active treatment with GLP-1 agonists
* Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism or history of or active acute pancreatitis.
* Acute (i.e. off hours, within hours surgery), Sub-acute surgery (i.e. the following days) are eligible.
* Known allergy towards Exenatide/Byetta or albumin (vehicle).
* 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.
* Recipient of any major organ transplant (e.g. lung, liver, heart)
* 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, …
What they're measuring
1
Time in days to the first occurring of the following co-primary end-points throughout the follow-up period