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Cardioprotective Effects of GLP-1 and Their Mechanisms

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ClinicalTrials.gov Identifier: NCT02128022
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : April 11, 2016
Sponsor:
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Angina Pectoris Drug: GLP-1 (7-36) amide Drug: Glibenclamide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigation Into Cardioprotective Effect of Glucagon-like Peptide-1 and it's Mechanism of Action During Myocardial Ischaemia
Study Start Date : July 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
Drug Information available for: Glyburide

Arm Intervention/treatment
Experimental: GLP-1 (7-36) amide and Glibenclamide
Patients will receive 5mg Glibenclamide orally prior to PCI and infusion of GLP-1 (7-36) amide 1.2 pmol/Kg/min during PCI
Drug: GLP-1 (7-36) amide
Infusion of GLP-1 (7-36) amide 1.2 pmol/Kg/min

Drug: Glibenclamide
Oral Glibenclamide 5mg

Experimental: Glibenclamide alone
Glibenclamide 5 mg orally prior to PCI
Drug: Glibenclamide
Oral Glibenclamide 5mg

Active Comparator: GLP-1 (7-36) amide
GLP-1 (7-36) amide
Drug: GLP-1 (7-36) amide
Infusion of GLP-1 (7-36) amide 1.2 pmol/Kg/min

No Intervention: Saline control
0.9% saline only (no treatment with GLP-1 (7-36) amide or glibenclamide)



Primary Outcome Measures :
  1. Change in Isovlumetric Relaxation Constant - Tau (ms) [ Time Frame: Measured at the time of procedure ]
    The 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 Outcome Measures :
  1. Left Ventricular Ejection Fraction (%) [ Time Frame: Measured at the time of the procedure ]
    Ejection 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.

  2. Maximal rate of change with time of left ventricular pressure - dP/dt max (mmHg/s) [ Time Frame: Measured at the time of the procedure ]
    dP/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.

  3. Minimum rate of change with time of left ventricular pressure - dP/dt min (mmHg/s) [ Time Frame: Measured at the time of procedure ]
    dP/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.



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Ages Eligible for Study:   18 Years and older   (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 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

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): NCT02128022


Locations
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United Kingdom
Papworth Hospital
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Stephen P Hoole, MD Papworth Hospital NHS Foundation Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02128022     History of Changes
Other Study ID Numbers: P01900
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: April 2016

Keywords provided by Papworth Hospital NHS Foundation Trust:
Glucagon-Like Peptide 1
Angina Pectoris
Percutaneous Coronary Intervention
Ischemic Preconditioning
Myocardial Reperfusion Injury

Additional relevant MeSH terms:
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Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Glyburide
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins
Hypoglycemic Agents