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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedFirst Posted
Study publicly available on registry
September 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedApril 11, 2016
April 1, 2016
2.5 years
June 23, 2014
April 8, 2016
Conditions
Keywords
Outcome Measures
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.
Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)
Secondary Outcomes (2)
Improvement in RV systolic function (EF, dP/dt max), between control and GLP-1 groups.
Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)
Collaterals and microcirculatory differences between control and GLP-1 groups
Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)
Study Arms (2)
saline placebo infusion
PLACEBO COMPARATOR30 minute infusion of a saline placebo Right coronary artery percutaneous coronary intervention
GLP-1 infusion
EXPERIMENTAL30 minute infusion of GLP-1 Right coronary artery percutaneous coronary intervention
Interventions
30 minute placebo infusion used as a comparator to the GLP-1 infusion
Eligibility Criteria
You may qualify if:
- Age over 18
- Able to give informed consent
- Elective percutaneous intervention for a single vessel right coronary artery stenosis \>75%
- Normal right ventricular function
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Papworth Hospital NHS Foundation Turst
Cambridge, Cambridgeshire, CB23 3RE, United Kingdom
Related Publications (1)
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.
PMID: 21586690BACKGROUND
Study Officials
- STUDY CHAIR
Stephen P Hoole, BM BCh, MA, MD
Papworth Hospital NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2014
First Posted
September 10, 2014
Study Start
September 1, 2014
Primary Completion
March 1, 2017
Last Updated
April 11, 2016
Record last verified: 2016-04