<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/NCT03032627</url>
  </required_header>
  <id_info>
    <org_study_id>TRIMDFH 936207</org_study_id>
    <nct_id>NCT03032627</nct_id>
  </id_info>
  <brief_title>Identifying Targets of Maladaptive Metabolic Responses in Heart Failure</brief_title>
  <official_title>Identifying Targets of Maladaptive Metabolic Responses in Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AdventHealth Translational Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Florida Hospital Cardiovascular Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sanford-Burnham Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AdventHealth Translational Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the research is to help researchers understand changes in metabolism in&#xD;
      patients that develop heart failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 20, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">June 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analyses of collected tissues</measure>
    <time_frame>Restricted to the time around surgical procedure</time_frame>
    <description>Tissue samples collected during surgery will be analyzed by way of immunoblot and qrtPCR of mRNA for metabolic enzymes on neutralized acid extracts.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Cardiac surgery</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will be recruited by a coordinator through electronic medical record (EMR) searches to identify those undergoing left ventricle assist device (LVAD) implantation and explantation, heart transplant, valve replacement or repair, endomyocardial biopsy during catheterization, and arterial bypass surgery. Prior to the procedure, potential subjects will be informed about the clinical study and if interested, they will be consented.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Collection of discarded heart tissue</intervention_name>
    <description>Discarded heart tissue will be collected from patients undergoing the aforementioned cardiac surgeries.</description>
    <arm_group_label>Cardiac surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects are capable of giving informed consent.&#xD;
&#xD;
          2. Age 19-89&#xD;
&#xD;
          3. Diagnosis of chronic heart failure&#xD;
&#xD;
          4. Any patients scheduled for at least one of the following procedures:&#xD;
&#xD;
               1. LVAD implantation or as recipient for cardiac transplantation.&#xD;
&#xD;
               2. LVAD placement both as bridge to transplant and as destination therapy.&#xD;
&#xD;
               3. LVAD explantation&#xD;
&#xD;
               4. Valve replacement or repair&#xD;
&#xD;
               5. Catheterization and myocardial biopsy for idiopathic cardiomyopathy&#xD;
&#xD;
               6. Coronary artery bypass graft (CABG)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Life expectancy less than 2 weeks&#xD;
&#xD;
          2. Diagnosed with following co-morbidities: cancer, chronic kidney disease (GFR≤30 or&#xD;
             serum creatinine &gt;2.1), active infection or treatment with antibiotics or persistent&#xD;
             infectious disease (hepatitis, HIV, etc), cirrhosis, active substance abuse and/or&#xD;
             alcohol dependence (≥ 14 alcoholic beverages per week).&#xD;
&#xD;
        Control Myocardial Tissue from Donor Hearts Inclusion Criteria&#xD;
&#xD;
          1. Samples collected from non-failing hearts deemed unsuitable for transplantation by&#xD;
             TransLife because of either acute recipient issues or post-harvest evidence of&#xD;
             pathology or positive but benign serology.&#xD;
&#xD;
          2. Normal cardiac function from medical records&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pathological remodeling and extensive infarction with limited non-pathological regions&#xD;
             of myocardium.&#xD;
&#xD;
          2. Abnormal or impaired cardiac function from medical records, which are self&#xD;
             determinants for rejection as a donor organ.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard E Pratley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Translational Research Institute for Metabolism and Diabetes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Translational Research Institute for Metabolism and Diabetes</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Braunwald E. Heart failure. JACC Heart Fail. 2013 Feb;1(1):1-20. doi: 10.1016/j.jchf.2012.10.002. Epub 2013 Feb 4.</citation>
    <PMID>24621794</PMID>
  </reference>
  <reference>
    <citation>Franklyn JA. The molecular mechanisms of thyroid hormone action. Baillieres Clin Endocrinol Metab. 1988 Nov;2(4):891-909. doi: 10.1016/s0950-351x(88)80023-5. No abstract available.</citation>
    <PMID>2908318</PMID>
  </reference>
  <reference>
    <citation>Grosjean O, Bluemenstock D. [Pulmonary and renal transplantations in the dog treated by single and later repeated neonatal injections of bone marrow]. C R Seances Soc Biol Fil. 1967 Sep;161(3):733-7. No abstract available. French.</citation>
    <PMID>4229424</PMID>
  </reference>
  <reference>
    <citation>Heath DF. Subcellular aspects of the response to trauma. Br Med Bull. 1985 Jul;41(3):240-5. doi: 10.1093/oxfordjournals.bmb.a072057. No abstract available.</citation>
    <PMID>3896379</PMID>
  </reference>
  <reference>
    <citation>Ingwall JS, Weiss RG. Is the failing heart energy starved? On using chemical energy to support cardiac function. Circ Res. 2004 Jul 23;95(2):135-45. doi: 10.1161/01.RES.0000137170.41939.d9.</citation>
    <PMID>15271865</PMID>
  </reference>
  <reference>
    <citation>Suyama K, Goldstein J, Aebersold R, Kent S. Regarding the size of Rh proteins. Blood. 1991 Jan 15;77(2):411. No abstract available.</citation>
    <PMID>1898705</PMID>
  </reference>
  <reference>
    <citation>Blahos J, Mertl L, Gregor O, Kotas J, Reisenauer R. [Stimulating effect of hypercalcaemia on basal gastric secretion (author's transl)]. Cas Lek Cesk. 1974 Aug 2;113(31):944-7. No abstract available. Czech.</citation>
    <PMID>4410983</PMID>
  </reference>
  <reference>
    <citation>Bucci E, Mignogna MD. [Diagnosis and prevention of stress in dental patients]. Dent Cadmos. 1986 May 31;54(9):77-8, 80, 82. No abstract available. Italian.</citation>
    <PMID>3464497</PMID>
  </reference>
  <reference>
    <citation>Torok B. Microcomputer-based recording system for clinical electrophysiology. Doc Ophthalmol. 1990 Sep;75(2):189-97. doi: 10.1007/BF00146555.</citation>
    <PMID>2276319</PMID>
  </reference>
  <reference>
    <citation>Polak J, Kotrc M, Wedellova Z, Jabor A, Malek I, Kautzner J, Kazdova L, Melenovsky V. Lipolytic effects of B-type natriuretic peptide 1-32 in adipose tissue of heart failure patients compared with healthy controls. J Am Coll Cardiol. 2011 Sep 6;58(11):1119-25. doi: 10.1016/j.jacc.2011.05.042.</citation>
    <PMID>21884948</PMID>
  </reference>
  <reference>
    <citation>Collins S. A heart-adipose tissue connection in the regulation of energy metabolism. Nat Rev Endocrinol. 2014 Mar;10(3):157-63. doi: 10.1038/nrendo.2013.234. Epub 2013 Dec 3.</citation>
    <PMID>24296515</PMID>
  </reference>
  <reference>
    <citation>Kovacova Z, Tharp WG, Liu D, Wei W, Xie H, Collins S, Pratley RE. Adipose tissue natriuretic peptide receptor expression is related to insulin sensitivity in obesity and diabetes. Obesity (Silver Spring). 2016 Apr;24(4):820-8. doi: 10.1002/oby.21418. Epub 2016 Feb 17.</citation>
    <PMID>26887289</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03032627
org study id: TRIMDFH 936207
nct id: NCT03032627
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the research is to help researchers understand changes in metabolism in
      patients that develop heart failure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Analyses of collected tissues
time frame: Restricted to the time around surgical procedure
description: Tissue samples collected during surgery will be analyzed by way of immunoblot and qrtPCR of mRNA for metabolic enzymes on neutralized acid extracts.
arm group label: Cardiac surgery
arm group type: Other
description: Subjects will be recruited by a coordinator through electronic medical record (EMR) searches to identify those undergoing left ventricle assist device (LVAD) implantation and explantation, heart transplant, valve replacement or repair, endomyocardial biopsy during catheterization, and arterial bypass surgery. Prior to the procedure, potential subjects will be informed about the clinical study and if interested, they will be consented.
intervention type: Procedure
intervention name: Collection of discarded heart tissue
description: Discarded heart tissue will be collected from patients undergoing the aforementioned cardiac surgeries.
arm group label: Cardiac surgery
criteria: 
gender: All
minimum age: 19 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard E Pratley, MD
role: Principal Investigator
affiliation: Translational Research Institute for Metabolism and Diabetes
facility: 
country: United States
citation: Braunwald E. Heart failure. JACC Heart Fail. 2013 Feb;1(1):1-20. doi: 10.1016/j.jchf.2012.10.002. Epub 2013 Feb 4.
PMID: 24621794
citation: Franklyn JA. The molecular mechanisms of thyroid hormone action. Baillieres Clin Endocrinol Metab. 1988 Nov;2(4):891-909. doi: 10.1016/s0950-351x(88)80023-5. No abstract available.
PMID: 2908318
citation: Grosjean O, Bluemenstock D. [Pulmonary and renal transplantations in the dog treated by single and later repeated neonatal injections of bone marrow]. C R Seances Soc Biol Fil. 1967 Sep;161(3):733-7. No abstract available. French.
PMID: 4229424
citation: Heath DF. Subcellular aspects of the response to trauma. Br Med Bull. 1985 Jul;41(3):240-5. doi: 10.1093/oxfordjournals.bmb.a072057. No abstract available.
PMID: 3896379
citation: Ingwall JS, Weiss RG. Is the failing heart energy starved? On using chemical energy to support cardiac function. Circ Res. 2004 Jul 23;95(2):135-45. doi: 10.1161/01.RES.0000137170.41939.d9.
PMID: 15271865
citation: Suyama K, Goldstein J, Aebersold R, Kent S. Regarding the size of Rh proteins. Blood. 1991 Jan 15;77(2):411. No abstract available.
PMID: 1898705
citation: Blahos J, Mertl L, Gregor O, Kotas J, Reisenauer R. [Stimulating effect of hypercalcaemia on basal gastric secretion (author's transl)]. Cas Lek Cesk. 1974 Aug 2;113(31):944-7. No abstract available. Czech.
PMID: 4410983
citation: Bucci E, Mignogna MD. [Diagnosis and prevention of stress in dental patients]. Dent Cadmos. 1986 May 31;54(9):77-8, 80, 82. No abstract available. Italian.
PMID: 3464497
citation: Torok B. Microcomputer-based recording system for clinical electrophysiology. Doc Ophthalmol. 1990 Sep;75(2):189-97. doi: 10.1007/BF00146555.
PMID: 2276319
citation: Polak J, Kotrc M, Wedellova Z, Jabor A, Malek I, Kautzner J, Kazdova L, Melenovsky V. Lipolytic effects of B-type natriuretic peptide 1-32 in adipose tissue of heart failure patients compared with healthy controls. J Am Coll Cardiol. 2011 Sep 6;58(11):1119-25. doi: 10.1016/j.jacc.2011.05.042.
PMID: 21884948
citation: Collins S. A heart-adipose tissue connection in the regulation of energy metabolism. Nat Rev Endocrinol. 2014 Mar;10(3):157-63. doi: 10.1038/nrendo.2013.234. Epub 2013 Dec 3.
PMID: 24296515
citation: Kovacova Z, Tharp WG, Liu D, Wei W, Xie H, Collins S, Pratley RE. Adipose tissue natriuretic peptide receptor expression is related to insulin sensitivity in obesity and diabetes. Obesity (Silver Spring). 2016 Apr;24(4):820-8. doi: 10.1002/oby.21418. Epub 2016 Feb 17.
PMID: 26887289
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No