<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02236299</url>
  </required_header>
  <id_info>
    <org_study_id>P01851</org_study_id>
    <nct_id>NCT02236299</nct_id>
  </id_info>
  <brief_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</brief_title>
  <acronym>DREAM GLP-1</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Papworth Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Papworth Hospital NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The heart requires nutrients and oxygen carried in the blood to generate energy for healthy&#xD;
      pump function. Blood is supplied via heart vessels called coronary arteries. When the&#xD;
      arteries narrow the investigators call this coronary artery disease. Narrowing and blockage&#xD;
      of the coronary arteries can cause chest pain (angina), breathlessness (due to a reduction in&#xD;
      pump function) and if prolonged even irreversible muscle damage known as a heart attack. The&#xD;
      investigators can treat patients with coronary artery disease with drugs that reduce the&#xD;
      workload on the heart or with balloons and hollow metal tubes (stents) to open the narrowed&#xD;
      coronary arteries and improve the blood supply. These treatments can relieve angina, improve&#xD;
      breathlessness and avert heart muscle damage during a heart attack. A potential new&#xD;
      mechanistic effect is emerging by modulating the type of fuel used by the heart to generate&#xD;
      energy more efficiently has been tested in the left ventricle. This study is designed to see&#xD;
      if mechanistic effect provides the same protection in the right ventricle. It is hoped that&#xD;
      this may further improve heart pump function and reduce the size of a heart attack in&#xD;
      patients with coronary artery disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in RV diastolic dysfunction (Tau, dP/dt min) between control and GLP-1 groups.</measure>
    <time_frame>Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)</time_frame>
    <description>Tau - the time constant of diastolic relaxation is a sensitive measure of ventricular function.&#xD;
Control Group - 15 patients are randomised to receive a placebo saline infusion.&#xD;
GLP-1 Group - 15 patients are randomised to receive a GLP-1 infusion.&#xD;
Balloon Occlusion One - is performed at the start of the procedure and is a measure of baseline ventricular function.&#xD;
Balloon Occlusion Two - is performed directly after a 30 minute infusion of either the saline control or GLP-1.&#xD;
All measurements are performed while the patient is in the catheter laboratory.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in RV systolic function (EF, dP/dt max), between control and GLP-1 groups.</measure>
    <time_frame>Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)</time_frame>
    <description>EF - the Ejection Fraction is the percentage of blood ejected by the ventricle and is considered as a sensitive measure of ventricular function.&#xD;
Control Group - 15 patients are randomised to receive a placebo saline infusion.&#xD;
GLP-1 Group - 15 patients are randomised to receive a GLP-1 infusion.&#xD;
Balloon Occlusion One - is performed at the start of the procedure and is a measure of baseline ventricular function.&#xD;
Balloon Occlusion Two - is performed directly after a 30 minute infusion of either the saline control or GLP-1.&#xD;
All measurements are performed while the patient is in the catheter laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Collaterals and microcirculatory differences between control and GLP-1 groups</measure>
    <time_frame>Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)</time_frame>
    <description>Control Group - 15 patients are randomised to receive a placebo saline infusion.&#xD;
GLP-1 Group - 15 patients are randomised to receive a GLP-1 infusion.&#xD;
Balloon Occlusion One - is performed at the start of the procedure and is a measure of baseline ventricular function.&#xD;
Balloon Occlusion Two - is performed directly after a 30 minute infusion of either the saline control or GLP-1.&#xD;
All measurements are performed while the patient is in the catheter laboratory.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Right Coronary Artery Percutaneous Coronary Intervention</condition>
  <condition>Right Ventricular Diastolic Dysfunction</condition>
  <arm_group>
    <arm_group_label>saline placebo infusion</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>30 minute infusion of a saline placebo Right coronary artery percutaneous coronary intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GLP-1 infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 minute infusion of GLP-1 Right coronary artery percutaneous coronary intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Right Coronary Artery Percutaneous Coronary Intervention</intervention_name>
    <arm_group_label>GLP-1 infusion</arm_group_label>
    <arm_group_label>saline placebo infusion</arm_group_label>
    <other_name>Device - stent</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>saline placebo infusion</intervention_name>
    <description>30 minute placebo infusion used as a comparator to the GLP-1 infusion</description>
    <arm_group_label>saline placebo infusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GLP-1 Infusion</intervention_name>
    <description>30 minute infusion GLP-1</description>
    <arm_group_label>GLP-1 infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Elective percutaneous intervention for a single vessel right coronary artery stenosis&#xD;
             &gt;75%&#xD;
&#xD;
          -  Normal right ventricular function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe co-morbidity expected life (&lt;6months)&#xD;
&#xD;
          -  Nicorandil or a GLP-1 receptor agonist or DPP-4 inhibitor use&#xD;
&#xD;
          -  Women of child bearing age&#xD;
&#xD;
          -  Myocardial infarction within the previous 3 months&#xD;
&#xD;
          -  Previous coronary artery bypass graft to the RCA&#xD;
&#xD;
          -  Significant known left to right shunt&#xD;
&#xD;
          -  Permanent pacemaker&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen P Hoole, BM BCh, MA, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Papworth Hospital NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stephen P Hoole, BM BCh, MA, DM</last_name>
    <phone>01480 364119</phone>
    <email>stephen.hoole@papworth.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Richard G Axell, BEng, MSc</last_name>
    <phone>01223 348098</phone>
    <email>richard.axell@addenbrookes.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Papworth Hospital NHS Foundation Turst</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB23 3RE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarah Fielding, PhD</last_name>
      <phone>01480 364181</phone>
      <email>Sarah.Fielding@papworth.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Richard G Axell, BEng, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>21586690</PMID>
  </reference>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>June 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>April 8, 2016</last_update_submitted>
  <last_update_submitted_qc>April 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Right Coronary Artery</keyword>
  <keyword>Percutaneous Coronary Intervention</keyword>
  <keyword>Diastolic Dysfunction</keyword>
  <keyword>Glucagon-like peptide-1</keyword>
  <keyword>GLP-1</keyword>
  <keyword>Stunning</keyword>
  <keyword>Cardioprotection</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02236299
org study id: P01851
nct id: NCT02236299
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
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)
description: 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.
measure: 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)
description: 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.
measure: 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)
description: 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.
arm group label: saline placebo infusion
arm group type: Placebo Comparator
description: 30 minute infusion of a saline placebo Right coronary artery percutaneous coronary intervention
arm group label: GLP-1 infusion
arm group type: Experimental
description: 30 minute infusion of GLP-1 Right coronary artery percutaneous coronary intervention
intervention type: Procedure
intervention name: Right Coronary Artery Percutaneous Coronary Intervention
arm group label: GLP-1 infusion
arm group label: saline placebo infusion
other name: Device - stent
intervention type: Other
intervention name: saline placebo infusion
description: 30 minute placebo infusion used as a comparator to the GLP-1 infusion
arm group label: saline placebo infusion
intervention type: Other
intervention name: GLP-1 Infusion
description: 30 minute infusion GLP-1
arm group label: GLP-1 infusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Stephen P Hoole, BM BCh, MA, MD
role: Study Chair
affiliation: Papworth Hospital NHS Foundation Trust
last name: Stephen P Hoole, BM BCh, MA, DM
phone: 01480 364119
email: stephen.hoole@papworth.nhs.uk
last name: Richard G Axell, BEng, MSc
phone: 01223 348098
email: richard.axell@addenbrookes.nhs.uk
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
citation: 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.
PMID: 21586690
responsible party type: Sponsor