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)

April 8, 2016 updated by: Papworth Hospital NHS Foundation Trust

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
        • Recruiting
        • Papworth Hospital NHS Foundation Turst
        • Contact:
        • Principal Investigator:
          • Richard G Axell, BEng, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in RV diastolic dysfunction (Tau, dP/dt min) between control and GLP-1 groups.
Time Frame: 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.
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.
Time Frame: 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.
Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)
Collaterals and microcirculatory differences between control and GLP-1 groups
Time Frame: 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.
Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papworth Hospital NHS Foundation Trust

Investigators

  • Study Chair: Stephen P Hoole, BM BCh, MA, MD, Papworth Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Estimate)

April 11, 2016

Last Update Submitted That Met QC Criteria

April 8, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P01851

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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