Right Coronary Artery Percutaneous Coronary InterventionDREAM GLP-1NCT02236299
Diastolic RV EvAluation With Millar Catheter to Investigate the Effect of Glucagon-Like Peptide-1 (GLP-1) on Right Ventricular Function During Elective Coronary Angioplasty and Stenting
A study testing Right Coronary Artery Percutaneous Coronary Intervention and GLP-1 Infusion in people with Right Coronary Artery Percutaneous Coronary Intervention and Right Ventricular Diastolic Dysfunction, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The heart requires nutrients and oxygen carried in the blood to generate energy for healthy pump function. Blood is supplied via heart vessels called coronary arteries. When the arteries narrow the investigators call this coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Right Coronary Artery Percutaneous Coronary Intervention, Right Ventricular Diastolic Dysfunction
- What is being tested?
- Right Coronary Artery Percutaneous Coronary Intervention and GLP-1 Infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Mar 2017
- Phase
- Interventional
- 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 to 100 years
- 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 right coronary artery stenosis >75%
- Normal right ventricular function
Who cannot join
- Severe co-morbidity expected life (<6months)
- Nicorandil or a GLP-1 receptor agonist or DPP-4 inhibitor use
- Women of child bearing age
- Myocardial infarction within the previous 3 months
- Previous coronary artery bypass graft to the RCA
- Significant known left to right shunt
- Permanent pacemaker
- Atrial fibrillation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Papworth Hospital NHS Foundation Turst
Cambridge, Cambridgeshire, CB23 3RE
Sarah Fielding, PhD, 01480 364181, Sarah.Fielding@papworth.nhs.uk
Richard G Axell, BEng, MSc
About this study
Official title: Diastolic RV EvAluation With Millar Catheter to Investigate the Effect of Glucagon-Like Peptide-1 (GLP-1) on Right Ventricular Function During Elective Coronary Angioplasty and Stenting - DREAM GLP-1
The heart requires nutrients and oxygen carried in the blood to generate energy for healthy pump function. Blood is supplied via heart vessels called coronary arteries. When the arteries narrow the investigators call this coronary artery disease. Narrowing and blockage of the coronary arteries can cause chest pain (angina), breathlessness (due to a reduction in pump function) and if prolonged even irreversible muscle damage known as a heart attack. The investigators can treat patients with coronary artery disease with drugs that reduce the workload on the heart or with balloons and hollow metal tubes (stents) to open the narrowed coronary arteries and improve the blood supply. These treatments can relieve angina, improve breathlessness and avert heart muscle damage during a heart attack. A potential new mechanistic effect is emerging by modulating the type of fuel used by the heart to generate energy more efficiently has been tested in the left ventricle. This study is designed to see if mechanistic effect provides the same protection in the right ventricle. It is hoped that this may further improve heart pump function and reduce the size of a heart attack in patients with coronary artery disease.
- Conditions
- Right Coronary Artery Percutaneous Coronary Intervention, Right Ventricular Diastolic Dysfunction
- Being tested
- Right Coronary Artery Percutaneous Coronary Intervention, saline placebo infusion, GLP-1 Infusion
- Keywords
- Right Coronary Artery, Percutaneous Coronary Intervention, Diastolic Dysfunction, Glucagon-like peptide-1, GLP-1, Stunning, Cardioprotection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Coronary Artery Percutaneous Coronary InterventionProcedure or surgery
Also called Device - stent
saline placebo infusionOther
30 minute placebo infusion used as a comparator to the GLP-1 infusion
GLP-1 InfusionOther
30 minute infusion GLP-1
| Study group | Role | What they receive |
|---|---|---|
| saline placebo infusion | Placebo comparator | 30 minute infusion of a saline placebo Right coronary artery percutaneous coronary intervention Receives: Procedure: Right Coronary Artery Percutaneous Coronary Intervention; Other: saline placebo infusion |
| GLP-1 infusion | Experimental | 30 minute infusion of GLP-1 Right coronary artery percutaneous coronary intervention Receives: Procedure: Right Coronary Artery Percutaneous Coronary Intervention; Other: GLP-1 Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in RV diastolic dysfunction (Tau, dP/dt min) between control and GLP-1 groups.
Tau - the time constant of diastolic relaxation is a sensitive measure of ventricular function.
Control Group - 15 patients are randomised to receive a placebo saline infusion.
GLP-1 Group - 15 patients are randomised to receive a GLP-1 infusion.
Balloon Occlusion One - is performed at the start of the procedure and is a measure of baseline ventricular function.
Balloon Occlusion Two - is performed directly after a 30 minute infusion of either the saline control or GLP-1.
All measurements are performed while the patient is in the catheter laboratory.
Measured: Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)
Secondary outcomes (2)
Improvement in RV systolic function (EF, dP/dt max), between control and GLP-1 groups.
EF - the Ejection Fraction is the percentage of blood ejected by the ventricle and is considered as a sensitive measure of ventricular function.
Control Group - 15 patients are randomised to receive a placebo saline infusion.
GLP-1 Group - 15 patients are randomised to receive a GLP-1 infusion.
Balloon Occlusion One - is performed at the start of the procedure and is a measure of baseline ventricular function.
Balloon Occlusion Two - is performed directly after a 30 minute infusion of either the saline control or GLP-1.
All measurements are performed while the patient is in the catheter laboratory.
Measured: Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)
Collaterals and microcirculatory differences between control and GLP-1 groups
Control Group - 15 patients are randomised to receive a placebo saline infusion.
GLP-1 Group - 15 patients are randomised to receive a GLP-1 infusion.
Balloon Occlusion One - is performed at the start of the procedure and is a measure of baseline ventricular function.
Balloon Occlusion Two - is performed directly after a 30 minute infusion of either the saline control or GLP-1.
All measurements are performed while the patient is in the catheter laboratory.
Measured: Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2017 (estimated)
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 Right Coronary Artery Percutaneous Coronary InterventionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Stephen P Hoole, BM BCh, MA, MD, Study chair, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236299
- Sponsor's protocol ID
- P01851
- Acronym
- DREAM GLP-1
- Status last verified
- Apr 2016
- First submitted
- 23 Jun 2014
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Read PA, Hoole SP, White PA, Khan FZ, O'Sullivan M, West NE, Dutka DP. A pilot study to assess whether glucagon-like peptide-1 protects the heart from ischemic dysfunction and attenuates stunning after coronary balloon occlusion in humans. Circ Cardiovasc Interv. 2011 Jun;4(3):266-72. doi: 10.1161/CIRCINTERVENTIONS.110.960476. Epub 2011 May 17.
PubMed 21586690
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
- Diastolic RV EvAluation With Millar Catheter to Investigate the Effect of Glucagon-Like Peptide-1 (GLP-1) on Right Ventricular Function During Elective Coronary Angioplasty and Stenting - DREAM GLP-1
- ClinicalTrials.gov ID
- NCT02236299
- Acronym / sponsor ID
- DREAM GLP-1 / P01851
- Conditions
- Right Coronary Artery Percutaneous Coronary Intervention, Right Ventricular Diastolic Dysfunction
- Keywords
- Right Coronary Artery, Percutaneous Coronary Intervention, Diastolic Dysfunction, Glucagon-like peptide-1, GLP-1, Stunning, Cardioprotection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- Sep 2014
- Primary completion
- Mar 2017 (estimated)
- First posted
- 10 Sep 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.
The heart requires nutrients and oxygen carried in the blood to generate energy for healthy pump function. Blood is supplied via heart vessels called coronary arteries. When the arteries narrow the investigators call this coronary artery disease. Narrowing and blockage of the coronary arteries can cause chest pain (angina), breathlessness (due to a reduction in pump function) and if prolonged even irreversible muscle damage known as a heart attack. The investigators can treat patients with coronary artery disease with drugs that reduce the workload on the heart or with balloons and hollow metal tubes (stents) to open the narrowed coronary arteries and improve the blood supply. These treatments can relieve angina, improve breathlessness and avert heart muscle damage during a heart attack. A potential new mechanistic effect is emerging by modulating the type of fuel used by the heart to generate energy more efficiently has been tested in the left ventricle. This study is designed to see if mechanistic effect provides the same protection in the right ventricle. It is hoped that this may further improve heart pump function and reduce the size of a heart attack in patients with coronary artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saline placebo infusion | Placebo comparator | Procedure: Right Coronary Artery Percutaneous Coronary Intervention, Other: saline placebo infusion30 minute infusion of a saline placebo Right coronary artery percutaneous coronary intervention |
| GLP-1 infusion | Experimental | Procedure: Right Coronary Artery Percutaneous Coronary Intervention, Other: GLP-1 Infusion30 minute infusion of GLP-1 Right coronary artery percutaneous coronary intervention |
Who may qualify
- Ages
- 18 to 100 years
- 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 right coronary artery stenosis >75%
- Normal right ventricular function
Key exclusion criteria (8 listed)
- Severe co-morbidity expected life (<6months)
- Nicorandil or a GLP-1 receptor agonist or DPP-4 inhibitor use
- Women of child bearing age
- Myocardial infarction within the previous 3 months
- Previous coronary artery bypass graft to the RCA
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 |
|---|---|---|
| Right Coronary Artery Percutaneous Coronary InterventionAlso: Device - stent | Procedure or surgery | GLP-1 infusion, saline placebo infusion |
| saline placebo infusion30 minute placebo infusion used as a comparator to the GLP-1 infusion | Other | saline placebo infusion |
| GLP-1 Infusion30 minute infusion GLP-1 | Other | GLP-1 infusion |
Primary outcome
Improvement in RV diastolic dysfunction (Tau, dP/dt min) between control and GLP-1 groups.
Time frame: Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)
Tau - the time constant of diastolic relaxation is a sensitive measure of ventricular function. Control Group - 15 patients are randomised to receive a placebo saline infusion. GLP-1 Group - 15 patients are randomised to receive a GLP-1 infusion. Balloon Occlusion One - is performed at the start of the procedure and is a measure of baseline ventricular function. Balloon Occlusion Two - is performed directly after a 30 minute infusion of either the saline control or GLP-1. All measurements are performed while the patient is in the catheter laboratory.
2 secondary outcomes
Improvement in RV systolic function (EF, dP/dt max), between control and GLP-1 groups.
Time frame: Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)
Collaterals and microcirculatory differences between control and GLP-1 groups
Time frame: Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Background: PubMed 21586690Read PA, Hoole SP, White PA, Khan FZ, O'Sullivan M, West NE, Dutka DP. A pilot study to assess whether glucagon-like peptide-1 protects the heart from ischemic dysfunction and attenuates stunning after coronary balloon occlusion in humans. Circ Cardiovasc Interv. 2011 Jun;4(3):266-72. doi: 10.1161/CIRCINTERVENTIONS.110.960476. Epub 2011 May 17.
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, BM BCh, MA, MD study chair
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 study testing Right Coronary Artery Percutaneous Coronary Intervention and GLP-1 Infusion in people with Right Coronary Artery Percutaneous Coronary Intervention and Right Ventricular Diastolic Dysfunction, 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 8 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: status not confirmed, 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen P Hoole, BM BCh, MA, DM (01480 364119, stephen.hoole@papworth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in RV diastolic dysfunction (Tau, dP/dt min) between control and GLP-1 groups. (time frame: Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)). 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 NCT02236299, 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.