Angina PectorisPhase 1NCT02128022
Cardioprotective Effects of GLP-1 and Their Mechanisms
A Phase 1 study testing GLP-1 (7-36) amide and Glibenclamide in people with Angina Pectoris, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- GLP-1 (7-36) amide and Glibenclamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18
- Able to give informed consent
- Elective percutaneous intervention for a single vessel coronary stenosis
- Normal left ventricular function
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Papworth Hospital
Cambridge, Cambridgeshire, CB23 3RE
About this study
Official title: Investigation Into Cardioprotective Effect of Glucagon-like Peptide-1 and it's Mechanism of Action During Myocardial Ischaemia
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.
- Conditions
- Angina Pectoris
- Being tested
- GLP-1 (7-36) amide, Glibenclamide
- Keywords
- Glucagon-Like Peptide 1, Angina Pectoris, Percutaneous Coronary Intervention, Ischemic Preconditioning, Myocardial Reperfusion Injury
- Medical subject headings
- Angina Pectoris, Myocardial Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 (7-36) amideDrug
Infusion of GLP-1 (7-36) amide 1.2 pmol/Kg/min
GlibenclamideDrug
Oral Glibenclamide 5mg
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 (7-36) amide and Glibenclamide | Experimental | Patients will receive 5mg Glibenclamide orally prior to PCI and infusion of GLP-1 (7-36) amide 1.2 pmol/Kg/min during PCI Receives: Drug: GLP-1 (7-36) amide; Drug: Glibenclamide |
| Glibenclamide alone | Experimental | Glibenclamide 5 mg orally prior to PCI Receives: Drug: Glibenclamide |
| GLP-1 (7-36) amide | Active comparator | GLP-1 (7-36) amide Receives: Drug: GLP-1 (7-36) amide |
| Saline control | No intervention | 0.9% saline only (no treatment with GLP-1 (7-36) amide or glibenclamide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Isovlumetric Relaxation Constant - Tau (ms)
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.
Measured: Measured at the time of procedure
Secondary outcomes (3)
Left Ventricular Ejection Fraction (%)
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.
Measured: Measured at the time of the procedure
Maximal rate of change with time of left ventricular pressure - dP/dt max (mmHg/s)
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.
Measured: Measured at the time of the procedure
Minimum rate of change with time of left ventricular pressure - dP/dt min (mmHg/s)
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.
Measured: Measured at the time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Stephen P Hoole, MD, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128022
- Sponsor's protocol ID
- P01900
- Status last verified
- Apr 2016
- First submitted
- 24 Apr 2014
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Giblett JP, Axell RG, White PA, Clarke SJ, McCormick L, Read PA, Reinhold J, Brown AJ, O'Sullivan M, West NE, Dutka DP, Hoole SP. Glucagon-like peptide-1 derived cardioprotection does not utilize a KATP-channel dependent pathway: mechanistic insights from human supply and demand ischemia studies. Cardiovasc Diabetol. 2016 Jul 19;15:99. doi: 10.1186/s12933-016-0416-3.
PubMed 27431258
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into Cardioprotective Effect of Glucagon-like Peptide-1 and it's Mechanism of Action During Myocardial Ischaemia
- ClinicalTrials.gov ID
- NCT02128022
- Acronym / sponsor ID
- P01900
- Conditions
- Angina Pectoris
- Keywords
- Glucagon-Like Peptide 1, Angina Pectoris, Percutaneous Coronary Intervention, Ischemic Preconditioning, Myocardial Reperfusion Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- Jul 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GLP-1 (7-36) amide and Glibenclamide | Experimental | Drug: GLP-1 (7-36) amide, Drug: GlibenclamidePatients will receive 5mg Glibenclamide orally prior to PCI and infusion of GLP-1 (7-36) amide 1.2 pmol/Kg/min during PCI |
| Glibenclamide alone | Experimental | Drug: GlibenclamideGlibenclamide 5 mg orally prior to PCI |
| GLP-1 (7-36) amide | Active comparator | Drug: GLP-1 (7-36) amideGLP-1 (7-36) amide |
| Saline control | No intervention | –0.9% saline only (no treatment with GLP-1 (7-36) amide or glibenclamide) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18
- Able to give informed consent
- Elective percutaneous intervention for a single vessel coronary stenosis
- Normal left ventricular function
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1 (7-36) amideInfusion of GLP-1 (7-36) amide 1.2 pmol/Kg/min | Drug | GLP-1 (7-36) amide, GLP-1 (7-36) amide and Glibenclamide |
| GlibenclamideOral Glibenclamide 5mg | Drug | GLP-1 (7-36) amide and Glibenclamide, Glibenclamide alone |
Primary outcome
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.
3 secondary outcomes
Left Ventricular Ejection Fraction (%)
Time frame: Measured at the time of the procedure
Maximal rate of change with time of left ventricular pressure - dP/dt max (mmHg/s)
Time frame: Measured at the time of the procedure
Minimum rate of change with time of left ventricular pressure - dP/dt min (mmHg/s)
Time frame: Measured at the time of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Derived from this study: PubMed 27431258Giblett JP, Axell RG, White PA, Clarke SJ, McCormick L, Read PA, Reinhold J, Brown AJ, O'Sullivan M, West NE, Dutka DP, Hoole SP. Glucagon-like peptide-1 derived cardioprotection does not utilize a KATP-channel dependent pathway: mechanistic insights from human supply and demand ischemia studies. Cardiovasc Diabetol. 2016 Jul 19;15:99. doi: 10.1186/s12933-016-0416-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen P Hoole, MD principal investigator
Papworth Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLP-1 (7-36) amide and Glibenclamide in people with Angina Pectoris, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Isovlumetric Relaxation Constant - Tau (ms) (time frame: Measured at the time of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02128022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2016.