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

Condition(s) targeted: Right Coronary Artery Percutaneous Coronary Intervention; Right Ventricular Diastolic Dysfunction

Intervention: Right Coronary Artery Percutaneous Coronary Intervention (Procedure); saline placebo infusion (Other); GLP-1 Infusion (Other)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Papworth Hospital NHS Foundation Trust

Official(s) and/or principal investigator(s):
Stephen P Hoole, BM BCh, MA, MD, Study Chair, Affiliation: Papworth Hospital

Overall contact:
Stephen P Hoole, BM BCh, MA, DM, Phone: 01480 364119, Email: stephen.hoole@papworth.nhs.uk

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: 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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Improvement in RV diastolic dysfunction (Tau, dP/dt min) between control and GLP-1 groups.

Secondary outcome:

Improvement in RV systolic function (EF, dP/dt max), between control and GLP-1 groups.

Collaterals and microcirculatory differences between control and GLP-1 groups

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Stephen P Hoole, BM BCh, MA, DM, Phone: 01480 364119, Email: stephen.hoole@papworth.nhs.uk

Papworth Hospital NHS Foundation Turst, Cambridge, Cambridgeshire CB23 3RE, United Kingdom; Not yet recruiting
Sarah Fielding, PhD, Phone: 01480 364181, Email: Sarah.Fielding@papworth.nhs.uk
Richard G Axell, BEng, MSc, Principal Investigator

Related publications:

Read PA, Hoole SP, White PA, Khan FZ, O'Sullivan M, West NE, Dutka DP. A pilot study to assess whether glucagon-like peptide-1 protects the heart from ischemic dysfunction and attenuates stunning after coronary balloon occlusion in humans. Circ Cardiovasc Interv. 2011 Jun;4(3):266-72. doi: 10.1161/CIRCINTERVENTIONS.110.960476. Epub 2011 May 17.

Starting date: September 2014
Last updated: September 8, 2014