Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6562
Study information
Scientific title
Investigation of the effect of GLP-1 and left ventricular function during myocardial ischaemia
Acronym
GLP-1 and left ventricular function during ischaemia
Study hypothesis
The hypothesis is that infusion of glucagon-like peptide-1 will protect the heart from ischaemia and improve left ventricular (LV) function during dobutamine stress echocardiography in patients with coronary artery disease
Ethics approval
MREC approved, ref: 08/H0304/68
Study design
Single-centre non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
Intervention
In the active DSE, patients will receive an infusion of GLP-1 intravenously at 1.2 pmol/kg/min starting 30 minutes prior to the DSE and continuing for 30 minutes into recovery. In the control scan there will be no infusion.
Intervention type
Drug
Phase
Not Applicable
Drug names
Glucagon-like peptide-1
Primary outcome measure
Global LV function at peak stress
Secondary outcome measures
1. Global LV function at 30 minutes recovery
2. Regional wall LV function at 30 minutes recovery
3. Regional wall LV function at peak stress
Overall trial start date
17/06/2009
Overall trial end date
30/07/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned sample size: 30; UK sample size: 30
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
17/06/2009
Recruitment end date
30/07/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Cambridge
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Cambridge University Hospitals NHS Foundation Trust (UK)
Sponsor details
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21561896
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26253538
Publication citations
-
Results
Read PA, Khan FZ, Dutka DP, Cardioprotection against ischaemia induced by dobutamine stress using glucagon-like peptide-1 in patients with coronary artery disease., Heart, 2012, 98, 5, 408-413, doi: 10.1136/hrt.2010.219345.
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Results
McCormick LM, Heck PM, Ring LS, Kydd AC, Clarke SJ, Hoole SP, Dutka DP, Glucagon-like peptide-1 protects against ischemic left ventricular dysfunction during hyperglycemia in patients with coronary artery disease and type 2 diabetes mellitus, Cardiovasc Diabetol, 2015, 14, 102, doi: 10.1186/s12933-015-0259-3.