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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Papworth Hospital NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P01851

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