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)

NHS Foundation Trust

Status: Unknown

Conditions: Right Coronary Artery Percutaneous Coronary Intervention; Right Ventricular Diastolic Dysfunction

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02236299

P01851

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

saline placebo infusion

Placebo Comparator group

Description:

30 minute infusion of a saline placebo Right coronary artery percutaneous coronary intervention

Treatment:

Procedure: Right Coronary Artery Percutaneous Coronary Intervention

Other: saline placebo infusion

GLP-1 infusion

Experimental group

Description:

30 minute infusion of GLP-1 Right coronary artery percutaneous coronary intervention

Treatment:

Other: GLP-1 Infusion

Procedure: Right Coronary Artery Percutaneous Coronary Intervention