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

Not Applicable

• Conditions: Right Ventricular Diastolic Dysfunction; Right Coronary Artery Percutaneous Coronary Intervention
• Interventions: Procedure: Right Coronary Artery Percutaneous Coronary Intervention; Other: saline placebo infusion; Other: GLP-1 Infusion

• Registration Number: NCT02236299
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-23
• Study Start: 2014-09
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-10
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-08
• Last Update Posted: 2016-04-11
• Primary Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline placebo infusion	saline placebo infusion	30 minute infusion of a saline placebo Right coronary artery percutaneous coronary intervention
GLP-1 infusion	GLP-1 Infusion	30 minute infusion of GLP-1 Right coronary artery percutaneous coronary intervention
saline placebo infusion	Right Coronary Artery Percutaneous Coronary Intervention	30 minute infusion of a saline placebo Right coronary artery percutaneous coronary intervention
GLP-1 infusion	Right Coronary Artery Percutaneous Coronary Intervention	30 minute infusion of GLP-1 Right coronary artery percutaneous coronary intervention

Primary Outcome Measures

Name	Time	Method
Improvement in RV diastolic dysfunction (Tau, dP/dt min) between control and GLP-1 groups.	Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)	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.

Secondary Outcome Measures

Name	Time	Method
Improvement in RV systolic function (EF, dP/dt max), between control and GLP-1 groups.	Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)	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.
Collaterals and microcirculatory differences between control and GLP-1 groups	Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)	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.

Trial Locations

Locations (1)

Papworth Hospital NHS Foundation Turst; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom