<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/NCT04481919</url>
  </required_header>
  <id_info>
    <org_study_id>190690</org_study_id>
    <nct_id>NCT04481919</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Trial of urinE chemiStry Guided aCute heArt faiLure treATmEnt (ESCALATE)</brief_title>
  <acronym>ESCALATE</acronym>
  <official_title>A Randomized Trial of Protocolized Diuretic Therapy Compared to Standard Care in Emergency Department Patients With Acute Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized trial of protocolized diuretic therapy guided by urinary sodium compared&#xD;
      to structured usual care in ED patients with AHF. Participants will be recruited following an&#xD;
      initial standard evaluation in the ED and randomized in a 1:1 fashion to structured usual&#xD;
      care or protocolized diuretic therapy guided by urinary sodium.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A standardized protocol driven treatment pathway for hospitalized patients started in the&#xD;
      first few hours of ED evaluation and utilizing objective measures of diuretic response is&#xD;
      needed. The investigators believe this would maximize diuretic efficiency, facilitate quicker&#xD;
      resolution of congestion, avoid WHF and prolonged LOS, and reduce AHF readmissions. Propr&#xD;
      data suggests low urine sodium predicts length of stay and outcomes after initial diuretic&#xD;
      dosing in the outpatient and inpatient setting. Further, use of our pathway using spot urine&#xD;
      sodium to titrate subsequent loop diuretic doses and maximize response in inpatients with AHF&#xD;
      has shown compelling improvements in congestion and weight loss. However, a randomized trial&#xD;
      is necessary to determine if initiating this protocol ,started in the ED, will improve AHF&#xD;
      outcomes relative to structured usual care. Specifically, the investigators hypothesize use&#xD;
      of spot urine sodium guided diuretic therapy will result in significant improvement in days&#xD;
      of benefit over the 14 days after randomization. Days of benefit combines patient symptoms&#xD;
      captured by global clinical status with clinical state quantifying the need for&#xD;
      hospitalization and IV diuresis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2022</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2026</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Two-arm comparison of structured usual care vs urinary sodium guided diuresis</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Triple blinded study of guideline-based care compared with a protocolized diuretic strategy using urinary sodium</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Status Score</measure>
    <time_frame>From the time of randomization through day 14</time_frame>
    <description>Daily composite of the clinical state and global clinical status (GCS), expressed as an integer ranging in value from 0 (deceased) to 15 (outpatient; best possible GCS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Congestion</measure>
    <time_frame>from the time of randomization until protocol transition to oral diuretics, approximately 14 days</time_frame>
    <description>Daily orthodema score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CV Death and AHF Readmission</measure>
    <time_frame>within 30 days of hospital discharge</time_frame>
    <description>Cardiovascular death and Acute Heart Failure Readmission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global clinical status (GCS)</measure>
    <time_frame>from the time of randomization through day 14</time_frame>
    <description>measured daily using a continuous scale of 1-100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in natriuretic peptides</measure>
    <time_frame>from the time of randomization until protocol transition to oral diuretics, approximately 14 days</time_frame>
    <description>Blood measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net fluid loss</measure>
    <time_frame>from the time of randomization until protocol transition to oral diuretics, approximately 14 days</time_frame>
    <description>difference between fluid input and urine output in ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total urine output</measure>
    <time_frame>from the time of randomization until protocol transition to oral diuretics, approximately 14 days</time_frame>
    <description>cumulative urine output in ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight Loss</measure>
    <time_frame>from the time of randomization until protocol transition to oral diuretics, approximately 14 days</time_frame>
    <description>cumulative weight loss in pounds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Home days</measure>
    <time_frame>within 30 days from randomization</time_frame>
    <description>Those days not in the hospital, rehab or a skilled nursing facility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shift in audiometry</measure>
    <time_frame>from the time of randomization until protocol transition to oral diuretics, approximately 14 days</time_frame>
    <description>Significant change in hearing threshold (dB) across frequencies from 250-8000 Hz</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative natriuresis</measure>
    <time_frame>from the time of randomization until protocol transition to oral diuretics, approximately 14 days</time_frame>
    <description>cumulative sodium excretion estimated using the NRPE (based on spot urine creatinine and sodium)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average daily natriuresis</measure>
    <time_frame>from the time of randomization until protocol transition to oral diuretics, approximately 14 days</time_frame>
    <description>mean daily sodium excretion estimated using the NRPE (based on spot urine creatinine and sodium)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Dyspnea score</measure>
    <time_frame>from the time of randomization until protocol transition to oral diuretics, approximately 14 days</time_frame>
    <description>measured daily using a continuous scale from 1-100</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Kidney injury biomarkers</measure>
    <time_frame>from the time of randomization until protocol transition to oral diuretics, approximately 14 days</time_frame>
    <description>changes in the urinary tubular injury markers including KIM-1 and NGAL</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of stay</measure>
    <time_frame>from the time of hospital admission to discharge, approximately 7 days</time_frame>
    <description>number of days in the hospital</description>
  </other_outcome>
  <other_outcome>
    <measure>180-day all cause death</measure>
    <time_frame>within 180 days of hospital discharge</time_frame>
    <description>all-cause death</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypotension</measure>
    <time_frame>from the time of randomization through 7 days off diuretic protocol, or discharge</time_frame>
    <description>Incidence of symptomatic (lightheaded, chest pain) hypotension (SBP &lt; 80 mmHg confirmed on 2 successive measurements at least 30 minutes apart)</description>
  </other_outcome>
  <other_outcome>
    <measure>Acute Kidney Injury Differences in Epithelial sodium channel (ENaC) levels</measure>
    <time_frame>from the time of randomization through 7 days off diuretic protocol, or discharge</time_frame>
    <description>AKI (defined as a need for renal replacement therapy or KDIGO stage 2 or greater from a serum creatinine at randomization)</description>
  </other_outcome>
  <other_outcome>
    <measure>CV death or Myocardial Infarction (MI) during hospitalization</measure>
    <time_frame>from the time of randomization through 7 days off diuretic protocol, or discharge</time_frame>
    <description>CV death or MI as adjudicated by a clinical events committee</description>
  </other_outcome>
  <other_outcome>
    <measure>Ototoxicity or tinnitus</measure>
    <time_frame>from the time of randomization through 7 days off diuretic protocol, or discharge</time_frame>
    <description>Clinically significant ototoxicity or tinnitus as determined by the study team</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">474</enrollment>
  <condition>Heart Failure</condition>
  <condition>Acute Heart Failure</condition>
  <arm_group>
    <arm_group_label>Protocolized spot urine sodium guided diuretic therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will have a spot urine sodium and urine creatinine obtained. The urine and creatinine results will be input into the diuretic calculator and the diuretic dose will be chosen based on daily goals for urine output and net negative fluid balance. Performed 3 times per day, diuretic dosing will be individualized based on the proportion of 24-hour diuresis achieved since the prior IV diuretic dose. Every 24 hours new goals for urine output and net negative fluid balance are established based on the study and treatment team's assessment of residual congestion until protocol completion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Guideline-based care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will be placed on guideline-based diuretic dosing consistent with usual practice. The initial dose will be two times their home dose and will be subsequently adjusted by the treating team based on renal function and symptom severity. The treating team can increase or decrease the frequency and dose of diuretic based on urine output and clinical assessment. Patients in this arm also have urine collected 3 times per day by the bedside nurse to mirror the intervention arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Protocolized diuretic therapy</intervention_name>
    <description>The urine sodium, urine creatinine and serum creatinine results will be input into the diuretic calculator and the diuretic dose will be chosen based on daily goals for urine output and net negative fluid balance.</description>
    <arm_group_label>Protocolized spot urine sodium guided diuretic therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18&#xD;
&#xD;
          -  Emergency Department diagnosis of Acute Heart Failure (AHF)&#xD;
&#xD;
          -  Any one of the following:&#xD;
&#xD;
             i. Chest radiograph or lung ultrasound consistent with AHF ii. Jugular venous&#xD;
             distension iii. Pulmonary rales on auscultation iv. Lower extremity edema v. S3 gallop&#xD;
&#xD;
          -  &gt; 10 pounds of volume overload physician estimate or historical dry weight&#xD;
&#xD;
          -  IV diuretic ordered or planned to be during first 24 hours of ED or inpatient stay&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  End Stage Renal Disease (ESRD) requiring dialysis&#xD;
&#xD;
          -  Need for immediate intubation&#xD;
&#xD;
          -  Acute Coronary Syndrome - presentation consistent with myocardial ischemia AND new&#xD;
             ST-Segment elevation/depression&#xD;
&#xD;
          -  Temperature &gt; 100.5ºF&#xD;
&#xD;
          -  End Stage Heart Failure: transplant list or ventricular assist device&#xD;
&#xD;
          -  Concurrent use of ototoxic medications including intravenous aminoglycosides and&#xD;
             cisplatin&#xD;
&#xD;
          -  Systolic Blood Pressure &lt; 90 mmHg at time of consent&#xD;
&#xD;
          -  LV outflow obstruction, severe uncorrected stenotic valvular disease or severe&#xD;
             restrictive cardiomyopathy&#xD;
&#xD;
          -  Greater than 2 doses of IV diuretic administered at the time of screening from the&#xD;
             time of the hospital presentation leading to this admission (outside hospital time is&#xD;
             included)&#xD;
&#xD;
          -  Severe, uncorrected serum electrolyte abnormalities at the time of consent (serum&#xD;
             potassium &lt;3.0 mEq/L, magnesium &lt;1.0 mEq/L or sodium &lt;125 or &gt;150 mEq/l)&#xD;
&#xD;
          -  Lack of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sean P. Collins, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sean P. Collins, MD</last_name>
    <phone>615-936-0253</phone>
    <email>sean.collins@vumc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Karen F. Miller, RN</last_name>
    <phone>615-936-4790</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>VA Tennessee Valley Health Service</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sean P. Collins, MD</last_name>
      <phone>615-936-0253</phone>
      <email>sean.collins@vumc.org</email>
    </contact>
    <contact_backup>
      <last_name>Karen F. Miller, RN</last_name>
      <phone>615-936-4790</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sean P Collins, MD</last_name>
      <phone>615-936-0253</phone>
      <email>sean.collins@vumc.org</email>
    </contact>
    <contact_backup>
      <last_name>Karen F. Miller, RN</last_name>
      <phone>615-936-4790</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Sean Collins</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Diuretic Therapy</keyword>
  <keyword>Emergency Department</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>Yes</sharing_ipd>
    <ipd_description>The Publication Committee will authorize access to study data. Investigators must submit a proposal requesting approval to access our trial data. Our trial will participate in the NHLBI Central Repository for study data and specimens.&#xD;
All data access will follow guidelines described in the NHLBI Limited Access Data Policy.</ipd_description>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>The Publication Committee will authorize access to study data. Investigators must submit a proposal requesting approval to access our trial data. Our trial will participate in the NHLBI Central Repository for study data and specimens.&#xD;
All data access will follow guidelines described in the NHLBI Limited Access Data Policy</ipd_access_criteria>
  </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/NCT04481919
org study id: 190690
nct id: NCT04481919
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a randomized trial of protocolized diuretic therapy guided by urinary sodium compared
      to structured usual care in ED patients with AHF. Participants will be recruited following an
      initial standard evaluation in the ED and randomized in a 1:1 fashion to structured usual
      care or protocolized diuretic therapy guided by urinary sodium.
A standardized protocol driven treatment pathway for hospitalized patients started in the
      first few hours of ED evaluation and utilizing objective measures of diuretic response is
      needed. The investigators believe this would maximize diuretic efficiency, facilitate quicker
      resolution of congestion, avoid WHF and prolonged LOS, and reduce AHF readmissions. Propr
      data suggests low urine sodium predicts length of stay and outcomes after initial diuretic
      dosing in the outpatient and inpatient setting. Further, use of our pathway using spot urine
      sodium to titrate subsequent loop diuretic doses and maximize response in inpatients with AHF
      has shown compelling improvements in congestion and weight loss. However, a randomized trial
      is necessary to determine if initiating this protocol ,started in the ED, will improve AHF
      outcomes relative to structured usual care. Specifically, the investigators hypothesize use
      of spot urine sodium guided diuretic therapy will result in significant improvement in days
      of benefit over the 14 days after randomization. Days of benefit combines patient symptoms
      captured by global clinical status with clinical state quantifying the need for
      hospitalization and IV diuresis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two-arm comparison of structured usual care vs urinary sodium guided diuresis
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Triple blinded study of guideline-based care compared with a protocolized diuretic strategy using urinary sodium
measure: Clinical Status Score
time frame: From the time of randomization through day 14
description: Daily composite of the clinical state and global clinical status (GCS), expressed as an integer ranging in value from 0 (deceased) to 15 (outpatient; best possible GCS).
measure: Congestion
time frame: from the time of randomization until protocol transition to oral diuretics, approximately 14 days
description: Daily orthodema score
measure: CV Death and AHF Readmission
time frame: within 30 days of hospital discharge
description: Cardiovascular death and Acute Heart Failure Readmission
measure: Global clinical status (GCS)
time frame: from the time of randomization through day 14
description: measured daily using a continuous scale of 1-100
measure: Change in natriuretic peptides
time frame: from the time of randomization until protocol transition to oral diuretics, approximately 14 days
description: Blood measurement
measure: Net fluid loss
time frame: from the time of randomization until protocol transition to oral diuretics, approximately 14 days
description: difference between fluid input and urine output in ml
measure: Total urine output
time frame: from the time of randomization until protocol transition to oral diuretics, approximately 14 days
description: cumulative urine output in ml
measure: Weight Loss
time frame: from the time of randomization until protocol transition to oral diuretics, approximately 14 days
description: cumulative weight loss in pounds
measure: Home days
time frame: within 30 days from randomization
description: Those days not in the hospital, rehab or a skilled nursing facility
measure: Shift in audiometry
time frame: from the time of randomization until protocol transition to oral diuretics, approximately 14 days
description: Significant change in hearing threshold (dB) across frequencies from 250-8000 Hz
measure: Cumulative natriuresis
time frame: from the time of randomization until protocol transition to oral diuretics, approximately 14 days
description: cumulative sodium excretion estimated using the NRPE (based on spot urine creatinine and sodium)
measure: Average daily natriuresis
time frame: from the time of randomization until protocol transition to oral diuretics, approximately 14 days
description: mean daily sodium excretion estimated using the NRPE (based on spot urine creatinine and sodium)
measure: Dyspnea score
time frame: from the time of randomization until protocol transition to oral diuretics, approximately 14 days
description: measured daily using a continuous scale from 1-100
measure: Change in Kidney injury biomarkers
time frame: from the time of randomization until protocol transition to oral diuretics, approximately 14 days
description: changes in the urinary tubular injury markers including KIM-1 and NGAL
measure: Length of stay
time frame: from the time of hospital admission to discharge, approximately 7 days
description: number of days in the hospital
measure: 180-day all cause death
time frame: within 180 days of hospital discharge
description: all-cause death
measure: Hypotension
time frame: from the time of randomization through 7 days off diuretic protocol, or discharge
description: Incidence of symptomatic (lightheaded, chest pain) hypotension (SBP < 80 mmHg confirmed on 2 successive measurements at least 30 minutes apart)
measure: Acute Kidney Injury Differences in Epithelial sodium channel (ENaC) levels
time frame: from the time of randomization through 7 days off diuretic protocol, or discharge
description: AKI (defined as a need for renal replacement therapy or KDIGO stage 2 or greater from a serum creatinine at randomization)
measure: CV death or Myocardial Infarction (MI) during hospitalization
time frame: from the time of randomization through 7 days off diuretic protocol, or discharge
description: CV death or MI as adjudicated by a clinical events committee
measure: Ototoxicity or tinnitus
time frame: from the time of randomization through 7 days off diuretic protocol, or discharge
description: Clinically significant ototoxicity or tinnitus as determined by the study team
arm group label: Protocolized spot urine sodium guided diuretic therapy
arm group type: Active Comparator
description: Patients will have a spot urine sodium and urine creatinine obtained. The urine and creatinine results will be input into the diuretic calculator and the diuretic dose will be chosen based on daily goals for urine output and net negative fluid balance. Performed 3 times per day, diuretic dosing will be individualized based on the proportion of 24-hour diuresis achieved since the prior IV diuretic dose. Every 24 hours new goals for urine output and net negative fluid balance are established based on the study and treatment team's assessment of residual congestion until protocol completion.
arm group label: Guideline-based care
arm group type: No Intervention
description: Patients will be placed on guideline-based diuretic dosing consistent with usual practice. The initial dose will be two times their home dose and will be subsequently adjusted by the treating team based on renal function and symptom severity. The treating team can increase or decrease the frequency and dose of diuretic based on urine output and clinical assessment. Patients in this arm also have urine collected 3 times per day by the bedside nurse to mirror the intervention arm.
intervention type: Drug
intervention name: Protocolized diuretic therapy
description: The urine sodium, urine creatinine and serum creatinine results will be input into the diuretic calculator and the diuretic dose will be chosen based on daily goals for urine output and net negative fluid balance.
arm group label: Protocolized spot urine sodium guided diuretic therapy
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Sean P. Collins, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
last name: Sean P. Collins, MD
phone: 615-936-0253
email: sean.collins@vumc.org
last name: Karen F. Miller, RN
phone: 615-936-4790
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Sean Collins
investigator title: Professor
mesh term: Heart Failure
mesh term: Diuretics
sharing ipd: Yes
ipd description: The Publication Committee will authorize access to study data. Investigators must submit a proposal requesting approval to access our trial data. Our trial will participate in the NHLBI Central Repository for study data and specimens.
All data access will follow guidelines described in the NHLBI Limited Access Data Policy.
ipd info type: Clinical Study Report (CSR)
ipd access criteria: The Publication Committee will authorize access to study data. Investigators must submit a proposal requesting approval to access our trial data. Our trial will participate in the NHLBI Central Repository for study data and specimens.
All data access will follow guidelines described in the NHLBI Limited Access Data Policy