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Cardioprotective Effects of GLP-1 and Their Mechanisms

Investigation Into Cardioprotective Effect of Glucagon-like Peptide-1 and it's Mechanism of Action During Myocardial Ischaemia

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02128022
Enrollment
32
Registered
2014-05-01
Start date
2014-07-31
Completion date
2016-03-31
Last updated
2016-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris

Keywords

Glucagon-Like Peptide 1, Angina Pectoris, Percutaneous Coronary Intervention, Ischemic Preconditioning, Myocardial Reperfusion Injury

Brief summary

Ischaemic heart disease is the most common cause of death in the UK. Glucagon-like peptide-1 (GLP-1) has been demonstrated to protect the heart when it is deprived of blood supply (ischaemia). The mechanism for this protection is not clear. Similar protection occurs with ischaemic conditioning of the heart, which is dependent on potassium channel opening. The investigators intend to establish whether GLP-1 mediated protection shares a similar mechanistic pathway. In order to do this the investigators will measures pressure--volume loops generated in the main pumping chamber of the heart at the time of a percutaneous coronary intervention (stenting). Patients will be allocated to GLP-1 alone, GLP-1 with glibenclamide (a potassium channel blocking medication approved for human use), saline control or glibenclamide alone. The investigators hypothesis is that the effect of GLP-1 will be abrogated by use of glibenclamide.

Interventions

Infusion of GLP-1 (7-36) amide 1.2 pmol/Kg/min

DRUGGlibenclamide

Oral Glibenclamide 5mg

Sponsors

Papworth Hospital NHS Foundation Trust
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age over 18 * Able to give informed consent * Elective percutaneous intervention for a single vessel coronary stenosis * Normal left ventricular function

Exclusion criteria

* Severe Co-morbidity * Type 2 Diabetes Mellitus * Nicorandil, Sulphonylureas, DPP4 inhibitors, GLP-1 agonists or Insulin use * Women of child bearing age * Myocardial infarction in previous three months * Previous coronary artery bypass grafts

Design outcomes

Primary

MeasureTime frameDescription
Change in Isovlumetric Relaxation Constant - Tau (ms)Measured at the time of procedureThe isovolumetric relaxation constant, Tau, a measure of left ventricular diastolic function, will be measured during the second balloon occlusion of the coronary artery. This will be measured on pressure-volume loop using a conductance catheter.

Secondary

MeasureTime frameDescription
Left Ventricular Ejection Fraction (%)Measured at the time of the procedureEjection fraction, a measure of left ventricular systolic function, will be measured during the second balloon occlusion of the coronary artery. This will be measured on pressure-volume loop using a conductance catheter.
Maximal rate of change with time of left ventricular pressure - dP/dt max (mmHg/s)Measured at the time of the proceduredP/dt max, a measure of left ventricular systolic function, will be measured during the second balloon occlusion of the coronary artery. This will be measured on pressure-volume loop using a conductance catheter.
Minimum rate of change with time of left ventricular pressure - dP/dt min (mmHg/s)Measured at the time of proceduredP/dt min, a measure of left ventricular diastolic function, will be measured during the second balloon occlusion of the coronary artery. This will be measured on pressure-volume loop using a conductance catheter.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026