Cardioprotective Effects of GLP-1 and Their Mechanisms
- Registration Number
- NCT02128022
- Lead Sponsor
- Papworth Hospital NHS Foundation Trust
- Brief Summary
Ischaemic heart disease is the most common cause of death in the UK. Glucagon-like peptide-1 (GLP-1) has been demonstrated to protect the heart when it is deprived of blood supply (ischaemia). The mechanism for this protection is not clear. Similar protection occurs with ischaemic conditioning of the heart, which is dependent on potassium channel opening.
The investigators intend to establish whether GLP-1 mediated protection shares a similar mechanistic pathway. In order to do this the investigators will measures pressure--volume loops generated in the main pumping chamber of the heart at the time of a percutaneous coronary intervention (stenting). Patients will be allocated to GLP-1 alone, GLP-1 with glibenclamide (a potassium channel blocking medication approved for human use), saline control or glibenclamide alone.
The investigators hypothesis is that the effect of GLP-1 will be abrogated by use of glibenclamide.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- Age over 18
- Able to give informed consent
- Elective percutaneous intervention for a single vessel coronary stenosis
- Normal left ventricular function
- Severe Co-morbidity
- Type 2 Diabetes Mellitus
- Nicorandil, Sulphonylureas, DPP4 inhibitors, GLP-1 agonists or Insulin use
- Women of child bearing age
- Myocardial infarction in previous three months
- Previous coronary artery bypass grafts
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description GLP-1 (7-36) amide and Glibenclamide GLP-1 (7-36) amide Patients will receive 5mg Glibenclamide orally prior to PCI and infusion of GLP-1 (7-36) amide 1.2 pmol/Kg/min during PCI GLP-1 (7-36) amide GLP-1 (7-36) amide GLP-1 (7-36) amide Glibenclamide alone Glibenclamide Glibenclamide 5 mg orally prior to PCI GLP-1 (7-36) amide and Glibenclamide Glibenclamide Patients will receive 5mg Glibenclamide orally prior to PCI and infusion of GLP-1 (7-36) amide 1.2 pmol/Kg/min during PCI
- Primary Outcome Measures
Name Time Method Change in Isovlumetric Relaxation Constant - Tau (ms) Measured at the time of procedure The isovolumetric relaxation constant, Tau, a measure of left ventricular diastolic function, will be measured during the second balloon occlusion of the coronary artery. This will be measured on pressure-volume loop using a conductance catheter.
- Secondary Outcome Measures
Name Time Method Left Ventricular Ejection Fraction (%) Measured at the time of the procedure Ejection fraction, a measure of left ventricular systolic function, will be measured during the second balloon occlusion of the coronary artery. This will be measured on pressure-volume loop using a conductance catheter.
Maximal rate of change with time of left ventricular pressure - dP/dt max (mmHg/s) Measured at the time of the procedure dP/dt max, a measure of left ventricular systolic function, will be measured during the second balloon occlusion of the coronary artery. This will be measured on pressure-volume loop using a conductance catheter.
Minimum rate of change with time of left ventricular pressure - dP/dt min (mmHg/s) Measured at the time of procedure dP/dt min, a measure of left ventricular diastolic function, will be measured during the second balloon occlusion of the coronary artery. This will be measured on pressure-volume loop using a conductance catheter.
Trial Locations
- Locations (1)
Papworth Hospital
🇬🇧Cambridge, Cambridgeshire, United Kingdom