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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)

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ClinicalTrials.gov Identifier: NCT02236299
Recruitment Status : Unknown
Verified April 2016 by Papworth Hospital NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : September 10, 2014
Last Update Posted : April 11, 2016
Sponsor:
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust

Brief 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.

Condition or disease Intervention/treatment Phase
Right Coronary Artery Percutaneous Coronary Intervention Right Ventricular Diastolic Dysfunction Procedure: Right Coronary Artery Percutaneous Coronary Intervention Other: saline placebo infusion Other: GLP-1 Infusion Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2014
Estimated Primary Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Glucagon

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 Name: 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 Name: Device - stent

Other: GLP-1 Infusion
30 minute infusion GLP-1




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.




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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236299


Contacts
Contact: Stephen P Hoole, BM BCh, MA, DM 01480 364119 stephen.hoole@papworth.nhs.uk
Contact: Richard G Axell, BEng, MSc 01223 348098 richard.axell@addenbrookes.nhs.uk

Locations
United Kingdom
Papworth Hospital NHS Foundation Turst Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Contact: Sarah Fielding, PhD    01480 364181    Sarah.Fielding@papworth.nhs.uk   
Principal Investigator: Richard G Axell, BEng, MSc         
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Investigators
Study Chair: Stephen P Hoole, BM BCh, MA, MD Papworth Hospital

Publications:
Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02236299     History of Changes
Other Study ID Numbers: P01851
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: April 2016

Keywords provided by Papworth Hospital NHS Foundation Trust:
Right Coronary Artery
Percutaneous Coronary Intervention
Diastolic Dysfunction
Glucagon-like peptide-1
GLP-1
Stunning
Cardioprotection

Additional relevant MeSH terms:
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins