CClinicalTrials.gg
Status unknownNCT02236299DREAM GLP-1Updated Apr 11, 2016

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

An interventional study of Right Coronary Artery Percutaneous Coronary Intervention and saline placebo infusion in Right Coronary Artery Percutaneous Coronary Intervention and Right Ventricular Diastolic Dysfunction, sponsored by Papworth Hospital NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-04-11.

Sponsored by Papworth Hospital NHS Foundation Trust · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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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Conditions studied

  • Right Coronary Artery Percutaneous Coronary Intervention
  • Right Ventricular Diastolic Dysfunction

Keywords

  • Right Coronary Artery
  • Percutaneous Coronary Intervention
  • Diastolic Dysfunction
  • Glucagon-like peptide-1
  • GLP-1
  • Stunning
  • Cardioprotection
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In context

Lead sponsor

Papworth Hospital NHS Foundation Trust is the lead sponsor of 62 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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: saline placebo 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: GLP-1 Infusion

Interventions

  • ProcedureRight Coronary Artery Percutaneous Coronary Intervention

    Also known as: Device - stent

  • Othersaline placebo infusion

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

  • OtherGLP-1 Infusion

    30 minute infusion GLP-1

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)

Secondary outcomes

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

    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.

    Time frame: Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)

  2. Collaterals and microcirculatory differences between control and GLP-1 groups

    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.

    Time frame: Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)

07

Study locations

1 of 1 sites recruiting
  • Papworth Hospital NHS Foundation Turst
    Cambridge, Cambridgeshire CB23 3RE, United Kingdom
    Recruiting
08

References and documents

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. PubMed 21586690 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02236299
Lead sponsor
Papworth Hospital NHS Foundation Trust
Responsible party
Sponsor
First posted
Sep 10, 2014
Start date
Sep 2014
Primary completion
Mar 2017 (estimated)
Last update
Apr 11, 2016

Study contacts

Stephen P Hoole, BM BCh, MA, DM
Contact
stephen.hoole@papworth.nhs.uk
01480 364119
Richard G Axell, BEng, MSc
Contact
richard.axell@addenbrookes.nhs.uk
01223 348098
Stephen P Hoole, BM BCh, MA, MD
study chair · Papworth Hospital NHS Foundation Trust

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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