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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

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.

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Detailed Description

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Conditions

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Right Coronary Artery Percutaneous Coronary Intervention Right Ventricular Diastolic Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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saline placebo infusion

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

Group Type PLACEBO_COMPARATOR

Right Coronary Artery Percutaneous Coronary Intervention

Intervention Type PROCEDURE

saline placebo infusion

Intervention Type OTHER

30 minute placebo infusion used as a comparator to the GLP-1 infusion

GLP-1 infusion

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

Group Type EXPERIMENTAL

Right Coronary Artery Percutaneous Coronary Intervention

Intervention Type PROCEDURE

GLP-1 Infusion

Intervention Type OTHER

30 minute infusion GLP-1

Interventions

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Right Coronary Artery Percutaneous Coronary Intervention

Intervention Type PROCEDURE

saline placebo infusion

30 minute placebo infusion used as a comparator to the GLP-1 infusion

Intervention Type OTHER

GLP-1 Infusion

30 minute infusion GLP-1

Intervention Type OTHER

Other Intervention Names

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Device - stent

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No