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NCT Number: NCT02128022

Cardioprotective Effects of GLP-1 and Their Mechanisms

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.

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Key information

Conditions

Angina Pectoris Cardiomyopathies Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Myocardial Reperfusion Injury Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Papworth Hospital

Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLP-1 (7-36) amide

Drug

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

glibenclamide

Drug

Oral Glibenclamide 5mg

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Papworth Hospital NHS Foundation Trust

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 1, 2014
Registry last updated
Apr 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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