<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/NCT03245281</url>
  </required_header>
  <id_info>
    <org_study_id>MDT16014</org_study_id>
    <nct_id>NCT03245281</nct_id>
  </id_info>
  <brief_title>LINQ for impEdance meAsuremeNt While Off From HF Medication Study</brief_title>
  <acronym>LEAN HF</acronym>
  <official_title>LINQ for impEdance meAsuremeNt While Off From HF Medication Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic BRC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic BRC</source>
  <oversight_info>
    <has_dmc>No</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 this non-randomized, cross-over, unblinded, single-center feasibility study is&#xD;
      to assess the sensitivity of the LINQ ICM to measure derived-subcutaneous impedance in&#xD;
      patients with heart failure during periods when diuretics and/or HF-medication consumption is&#xD;
      increased or suspended for 48 hours (up to 72 hours at physician discretion) and to collect&#xD;
      safety information related to HF status and to medication consumption changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 30 subjects with a clinical diagnosis of Heart Failure will be enrolled in the study.&#xD;
      It is expected that the subjects will be enrolled over a period of approximately 6 months.&#xD;
&#xD;
      3 follow up visits are planned at 2, 4 and 6 months (+/- one week) following the LINQ ICM&#xD;
      implant.&#xD;
&#xD;
      The total expected duration of the study is of about 1 year. According to the enrolment&#xD;
      chronological order, each subject will be allocated to Diuretic Suspension group (DS),&#xD;
      Diuretic Increase (DI) or Diuretic+MRA medication Suspension (DMS), which will define the&#xD;
      medication regimen before the follow-up visit.&#xD;
&#xD;
      Primary objective of the study is detecting the variation of impedance magnitude and the time&#xD;
      of occurrence after medication regimen changes will be evaluated at each follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>According to the enrolment chronological order, each subject will be allocated to Diuretic Suspension group (DS), Diuretic Increase (DI) or Diuretic+MRA medication Suspension (DMS), which will define the medication regimen before the follow-up visit.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Derived-subcutaneous impedance</measure>
    <time_frame>2 months</time_frame>
    <description>The variation of impedance magnitude and the time of occurrence after medication regimen changes will be detected by the LINQ ICM</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Adverse Events</measure>
    <time_frame>6 months</time_frame>
    <description>All AEs related to changes in the therapeutic regimen and/or to HF status will be collected through CRF completion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Transitory Arrhythmias</measure>
    <time_frame>6 months</time_frame>
    <description>Any transitory arrhythmias related to drug regimen changes and/or HF condition will be collected through CRF completion</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Diuretic Suspension (DS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Diuretic Increase (DI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Diuretic and Medication Suspension (DMS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diuretic Suspension (DS)</intervention_name>
    <description>Stop diuretic consumption in the 48h before the follow-up visit</description>
    <arm_group_label>Diuretic Suspension (DS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diuretic Increase (DI)</intervention_name>
    <description>Double diuretics dosage in the 48h before the follow-up visit</description>
    <arm_group_label>Diuretic Increase (DI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diuretic and Medication Suspension (DMS)</intervention_name>
    <description>Stop diuretic and MRA medication consumption in the 48h before the follow-up visit</description>
    <arm_group_label>Diuretic and Medication Suspension (DMS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical Diagnosis of Heart Failure&#xD;
&#xD;
          -  Plasma NT-proBNP (&gt;250ng/L in SR and &gt;1,000ng/L in AF)&#xD;
&#xD;
          -  LVEF &lt;50% measured in the year before enrolment&#xD;
&#xD;
          -  Treated routinely with a daily dose of loop diuretic&#xD;
&#xD;
          -  Receiving other guideline-indicated therapy for heart failure&#xD;
&#xD;
          -  Willing to sign the informed consent form.&#xD;
&#xD;
          -  Greater than 18 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients (all females of child-bearing potential must have a negative&#xD;
             pregnancy test before LINQ ICM implant)&#xD;
&#xD;
          -  eGFR &lt;30 ml/minute.&#xD;
&#xD;
          -  Any concomitant condition which in the opinion of the investigator would not allow a&#xD;
             safe participation in the study.&#xD;
&#xD;
          -  Patients with implanted pacemakers or defibrillators&#xD;
&#xD;
          -  Severe aortic or mitral valve disease&#xD;
&#xD;
          -  Breathlessness at rest or on minor exertion.&#xD;
&#xD;
          -  Chest pain at rest or on mild or moderate exertion.&#xD;
&#xD;
          -  Patients deemed too unstable to miss 48 hours of heart failure treatment&#xD;
&#xD;
          -  Enrolled in another study that could confound the results of this study, without&#xD;
             documented pre-approval from Medtronic study manager&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Cleland, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>NHS Greater Glasgow &amp; Clyde</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Teodora Bellone</last_name>
    <phone>433566566</phone>
    <phone_ext>0031</phone_ext>
    <email>teodora.bellone@medtronic.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mirko De Melis</last_name>
    <email>mirko.de.melis@medtronic.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nhs Greater Glasgow &amp; Clyde</name>
      <address>
        <city>Glasgow</city>
        <zip>G12 0XH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clare Murphy, Dr</last_name>
      <email>claremurphy4@nhs.net</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thom T, Wilson M, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146. doi: 10.1161/CIRCULATIONAHA.107.187998. Epub 2007 Dec 17. No abstract available. Erratum In: Circulation. 2010 Jul 6;122(1):e10. Kissela, Bret [corrected to Kissela, Brett].</citation>
    <PMID>18086926</PMID>
  </reference>
  <reference>
    <citation>Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.</citation>
    <PMID>16079372</PMID>
  </reference>
  <reference>
    <citation>Butler J, Arbogast PG, Daugherty J, Jain MK, Ray WA, Griffin MR. Outpatient utilization of angiotensin-converting enzyme inhibitors among heart failure patients after hospital discharge. J Am Coll Cardiol. 2004 Jun 2;43(11):2036-43. doi: 10.1016/j.jacc.2004.01.041.</citation>
    <PMID>15172409</PMID>
  </reference>
  <reference>
    <citation>Monane M, Bohn RL, Gurwitz JH, Glynn RJ, Avorn J. Noncompliance with congestive heart failure therapy in the elderly. Arch Intern Med. 1994 Feb 28;154(4):433-7.</citation>
    <PMID>8117176</PMID>
  </reference>
  <reference>
    <citation>Mittal S, Sanders P, Pokushalov E, Dekker L, Kereiakes D, Schloss EJ, Pouliot E, Franco N, Zhong Y, DI Bacco M, Purerfellner H. Safety Profile of a Miniaturized Insertable Cardiac Monitor: Results from Two Prospective Trials. Pacing Clin Electrophysiol. 2015 Dec;38(12):1464-9. doi: 10.1111/pace.12752. Epub 2015 Oct 20.</citation>
    <PMID>26412309</PMID>
  </reference>
  <reference>
    <citation>Purerfellner H, Sanders P, Pokushalov E, Di Bacco M, Bergemann T, Dekker LR; Reveal LINQ Usability Study Investigators. Miniaturized Reveal LINQ insertable cardiac monitoring system: First-in-human experience. Heart Rhythm. 2015 Jun;12(6):1113-9. doi: 10.1016/j.hrthm.2015.02.030. Epub 2015 Feb 26.</citation>
    <PMID>25728756</PMID>
  </reference>
  <reference>
    <citation>van der Wal MH, Jaarsma T, van Veldhuisen DJ. Non-compliance in patients with heart failure; how can we manage it? Eur J Heart Fail. 2005 Jan;7(1):5-17. doi: 10.1016/j.ejheart.2004.04.007.</citation>
    <PMID>15642526</PMID>
  </reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>July 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>June 19, 2018</last_update_submitted>
  <last_update_submitted_qc>June 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diuretics</mesh_term>
  </intervention_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/NCT03245281
org study id: MDT16014
nct id: NCT03245281
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this non-randomized, cross-over, unblinded, single-center feasibility study is
      to assess the sensitivity of the LINQ ICM to measure derived-subcutaneous impedance in
      patients with heart failure during periods when diuretics and/or HF-medication consumption is
      increased or suspended for 48 hours (up to 72 hours at physician discretion) and to collect
      safety information related to HF status and to medication consumption changes.
Up to 30 subjects with a clinical diagnosis of Heart Failure will be enrolled in the study.
      It is expected that the subjects will be enrolled over a period of approximately 6 months.

      3 follow up visits are planned at 2, 4 and 6 months (+/- one week) following the LINQ ICM
      implant.

      The total expected duration of the study is of about 1 year. According to the enrolment
      chronological order, each subject will be allocated to Diuretic Suspension group (DS),
      Diuretic Increase (DI) or Diuretic+MRA medication Suspension (DMS), which will define the
      medication regimen before the follow-up visit.

      Primary objective of the study is detecting the variation of impedance magnitude and the time
      of occurrence after medication regimen changes will be evaluated at each follow-up.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: According to the enrolment chronological order, each subject will be allocated to Diuretic Suspension group (DS), Diuretic Increase (DI) or Diuretic+MRA medication Suspension (DMS), which will define the medication regimen before the follow-up visit.
primary purpose: Other
masking: None (Open Label)
measure: Derived-subcutaneous impedance
time frame: 2 months
description: The variation of impedance magnitude and the time of occurrence after medication regimen changes will be detected by the LINQ ICM
measure: Number of Adverse Events
time frame: 6 months
description: All AEs related to changes in the therapeutic regimen and/or to HF status will be collected through CRF completion
measure: Number of Transitory Arrhythmias
time frame: 6 months
description: Any transitory arrhythmias related to drug regimen changes and/or HF condition will be collected through CRF completion
arm group label: Diuretic Suspension (DS)
arm group type: Experimental
arm group label: Diuretic Increase (DI)
arm group type: Experimental
arm group label: Diuretic and Medication Suspension (DMS)
arm group type: Experimental
intervention type: Drug
intervention name: Diuretic Suspension (DS)
description: Stop diuretic consumption in the 48h before the follow-up visit
arm group label: Diuretic Suspension (DS)
intervention type: Drug
intervention name: Diuretic Increase (DI)
description: Double diuretics dosage in the 48h before the follow-up visit
arm group label: Diuretic Increase (DI)
intervention type: Drug
intervention name: Diuretic and Medication Suspension (DMS)
description: Stop diuretic and MRA medication consumption in the 48h before the follow-up visit
arm group label: Diuretic and Medication Suspension (DMS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Cleland, Prof
role: Study Chair
affiliation: NHS Greater Glasgow & Clyde
last name: Teodora Bellone
phone: 433566566
phone ext: 0031
email: teodora.bellone@medtronic.com
last name: Mirko De Melis
email: mirko.de.melis@medtronic.com
facility: 
status: Recruiting
contact: 
country: United Kingdom
citation: Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thom T, Wilson M, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146. doi: 10.1161/CIRCULATIONAHA.107.187998. Epub 2007 Dec 17. No abstract available. Erratum In: Circulation. 2010 Jul 6;122(1):e10. Kissela, Bret [corrected to Kissela, Brett].
PMID: 18086926
citation: Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
PMID: 16079372
citation: Butler J, Arbogast PG, Daugherty J, Jain MK, Ray WA, Griffin MR. Outpatient utilization of angiotensin-converting enzyme inhibitors among heart failure patients after hospital discharge. J Am Coll Cardiol. 2004 Jun 2;43(11):2036-43. doi: 10.1016/j.jacc.2004.01.041.
PMID: 15172409
citation: Monane M, Bohn RL, Gurwitz JH, Glynn RJ, Avorn J. Noncompliance with congestive heart failure therapy in the elderly. Arch Intern Med. 1994 Feb 28;154(4):433-7.
PMID: 8117176
citation: Mittal S, Sanders P, Pokushalov E, Dekker L, Kereiakes D, Schloss EJ, Pouliot E, Franco N, Zhong Y, DI Bacco M, Purerfellner H. Safety Profile of a Miniaturized Insertable Cardiac Monitor: Results from Two Prospective Trials. Pacing Clin Electrophysiol. 2015 Dec;38(12):1464-9. doi: 10.1111/pace.12752. Epub 2015 Oct 20.
PMID: 26412309
citation: Purerfellner H, Sanders P, Pokushalov E, Di Bacco M, Bergemann T, Dekker LR; Reveal LINQ Usability Study Investigators. Miniaturized Reveal LINQ insertable cardiac monitoring system: First-in-human experience. Heart Rhythm. 2015 Jun;12(6):1113-9. doi: 10.1016/j.hrthm.2015.02.030. Epub 2015 Feb 26.
PMID: 25728756
citation: van der Wal MH, Jaarsma T, van Veldhuisen DJ. Non-compliance in patients with heart failure; how can we manage it? Eur J Heart Fail. 2005 Jan;7(1):5-17. doi: 10.1016/j.ejheart.2004.04.007.
PMID: 15642526
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Diuretics
sharing ipd: No