Diastolic RV EvAluation With Millar Catheter to Investigate the Effect of Glucagon-Like Peptide-1 (GLP-1) on Right Ventricular Function During Elective Coronary Angioplasty and Stenting

Study Overview
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Brief Summary
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The heart requires nutrients and oxygen carried in the blood to generate energy for healthy pump function. Blood is supplied via heart vessels called coronary arteries. When the arteries narrow the investigators call this coronary artery disease. Narrowing and blockage of the coronary arteries can cause chest pain (angina), breathlessness (due to a reduction in pump function) and if prolonged even irreversible muscle damage known as a heart attack. The investigators can treat patients with coronary artery disease with drugs that reduce the workload on the heart or with balloons and hollow metal tubes (stents) to open the narrowed coronary arteries and improve the blood supply. These treatments can relieve angina, improve breathlessness and avert heart muscle damage during a heart attack. A potential new mechanistic effect is emerging by modulating the type of fuel used by the heart to generate energy more efficiently has been tested in the left ventricle. This study is designed to see if mechanistic effect provides the same protection in the right ventricle. It is hoped that this may further improve heart pump function and reduce the size of a heart attack in patients with coronary artery disease.

Official Title
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Diastolic RV EvAluation With Millar Catheter to Investigate the Effect of Glucagon-Like Peptide-1 (GLP-1) on Right Ventricular Function During Elective Coronary Angioplasty and Stenting - DREAM GLP-1

Conditions
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Right Coronary Artery Percutaneous Coronary Intervention, Right Ventricular Diastolic Dysfunction

Intervention / Treatment
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* Procedure: Right Coronary Artery Percutaneous Coronary Intervention
* Other: saline placebo infusion
* Other: GLP-1 Infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 Able to give informed consent Elective percutaneous intervention for a single vessel right coronary artery stenosis >75% Normal right ventricular function Exclusion Criteria: Severe co-morbidity expected life (<6months) Nicorandil or a GLP-1 receptor agonist or DPP-4 inhibitor use Women of child bearing age Myocardial infarction within the previous 3 months Previous coronary artery bypass graft to the RCA Significant known left to right shunt Permanent pacemaker Atrial fibrillation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline placebo infusion<br>30 minute infusion of a saline placebo Right coronary artery percutaneous coronary intervention | Procedure: Right Coronary Artery Percutaneous Coronary Intervention<br> <br> * Other names: Device - stent;Other: saline placebo infusion<br>* 30 minute placebo infusion used as a comparator to the GLP-1 infusion<br>|
| Experimental: GLP-1 infusion<br>30 minute infusion of GLP-1 Right coronary artery percutaneous coronary intervention | Procedure: Right Coronary Artery Percutaneous Coronary Intervention<br> <br> * Other names: Device - stent;Other: GLP-1 Infusion<br>* 30 minute infusion GLP-1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in RV diastolic dysfunction (Tau, dP/dt min) between control and GLP-1 groups. | Tau - the time constant of diastolic relaxation is a sensitive measure of ventricular function. Control Group - 15 patients are randomised to receive a placebo saline infusion. GLP-1 Group - 15 patients are randomised to receive a GLP-1 infusion. Balloon Occlusion One - is performed at the start of the procedure and is a measure of baseline ventricular function. Balloon Occlusion Two - is performed directly after a 30 minute infusion of either the saline control or GLP-1. All measurements are performed while the patient is in the catheter laboratory. | Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in RV systolic function (EF, dP/dt max), between control and GLP-1 groups. | EF - the Ejection Fraction is the percentage of blood ejected by the ventricle and is considered as a sensitive measure of ventricular function. Control Group - 15 patients are randomised to receive a placebo saline infusion. GLP-1 Group - 15 patients are randomised to receive a GLP-1 infusion. Balloon Occlusion One - is performed at the start of the procedure and is a measure of baseline ventricular function. Balloon Occlusion Two - is performed directly after a 30 minute infusion of either the saline control or GLP-1. All measurements are performed while the patient is in the catheter laboratory. | Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later) | 
| Collaterals and microcirculatory differences between control and GLP-1 groups | Control Group - 15 patients are randomised to receive a placebo saline infusion. GLP-1 Group - 15 patients are randomised to receive a GLP-1 infusion. Balloon Occlusion One - is performed at the start of the procedure and is a measure of baseline ventricular function. Balloon Occlusion Two - is performed directly after a 30 minute infusion of either the saline control or GLP-1. All measurements are performed while the patient is in the catheter laboratory. | Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Right Coronary Artery, Percutaneous Coronary Intervention, Diastolic Dysfunction, Glucagon-like peptide-1, GLP-1, Stunning, Cardioprotection