<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/NCT02993601</url>
  </required_header>
  <id_info>
    <org_study_id>RBH01</org_study_id>
    <nct_id>NCT02993601</nct_id>
  </id_info>
  <brief_title>Feasibility Study of a New Peripheral Oedema Monitor for Heart Failure</brief_title>
  <official_title>Evaluation of the Safety and Feasibility of a New Peripheral Oedema Monitor for Home and Clinical Use for Heart Failure Patients, Using the Heartfelt-1 Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heartfelt Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Royal Brompton &amp; Harefield NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Heartfelt Technologies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims at assessing the usefulness of the Heartfelt1 device in patients suffering&#xD;
      from heart failure, who have peripheral oedema. The device is non-contact and does not&#xD;
      requires patient compliance to work. It gives an output reading of the patient's lower leg&#xD;
      volume.&#xD;
&#xD;
      During the study, this measurement will be compared to clinical standard and gold standard&#xD;
      measurements as well as clinical grading of peripheral oedema.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Heartfelt-1 device is a CE (Conformité Européenne = European Conformity) mark medical&#xD;
      device used to measure biometric parameters of the foot and lower leg. The study aims at&#xD;
      assessing the usefulness in patients suffering from heart failure, who have peripheral&#xD;
      oedema. Models used for the measurements of foot and lower legs have not yet been validated&#xD;
      for this group of patients, who are likely to have feet with abnormal surface contours and&#xD;
      appearance secondary to oedema. Peripheral oedema can be a leading indicator of heart failure&#xD;
      de-compensation which can lead to hospitalisation of patients, and therefore the device could&#xD;
      be a useful clinical tool to monitor patients in their home. The Heartfelt-1 device has the&#xD;
      ability to recognise the patient's feet (amongst an average size household setting), and&#xD;
      trigger automatically the measurements when the feet are naked (for example as the patient&#xD;
      goes in and out of bed). This makes the device an obvious choice for patients with compliance&#xD;
      issues with current methods of monitoring (e.g. daily use of weighing scales) and treatment&#xD;
      (e.g. diuretics) if it could be validated in this patient group.&#xD;
&#xD;
      The study has two general aims:&#xD;
&#xD;
      The first is to collect a time-series of data on inpatients with peripheral oedema caused by&#xD;
      heart failure, as they receive intravenous or oral diuretic treatment to remove excess fluid&#xD;
      and achieve optimal body weight and fluid balance. This data will be used both to determine&#xD;
      the attainable resolution of foot biometric measurements on a patient as their fluid status&#xD;
      changes, and also to further develop the algorithms used in the device and make them usable&#xD;
      on a wide range of feet/lower legs which have been deformed by oedema. The data required for&#xD;
      this study are images taken using the Heartfelt-1 device, as well as validation measurements&#xD;
      such as the figure of eight using a medical grade tape measure, callipers, or the water&#xD;
      displacement method using a volumetric gauge, at multiple time-points whilst the peripheral&#xD;
      oedema reduces.&#xD;
&#xD;
      The second, on a second group of stable ambulatory (Heart Failure) HF patients with variable&#xD;
      levels of oedema, is to evaluate the performance of the Heartfelt-1 device in determining&#xD;
      foot biometric parameters one a wide range of patients at a single point in time. Patients&#xD;
      with stable chronic heart failure will have their foot/lower legs measured by the Heartfelt-1&#xD;
      device, as well as standard medical measurement (figure of eight using a medical grade tape&#xD;
      measure, callipers) and gold standard measurement (water displacement method using a gauge),&#xD;
      as well as the patient's weight and a clinical grading of oedema. These will be compared and&#xD;
      an estimate of the accuracy of the Heartfelt-1 device over this wider patient group can be&#xD;
      extrapolated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Actual">June 13, 2017</completion_date>
  <primary_completion_date type="Actual">June 13, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Volume as measured by the Heartfelt-1 device</measure>
    <time_frame>Within 3 months after patient recruitment or before the end of the study (whichever is soonest).</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Within 3 months after patient recruitment or before the end of the study (whichever is soonest).</time_frame>
    <description>Patient weight on the day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance measurements</measure>
    <time_frame>Within 3 months after patient recruitment or before the end of the study (whichever is soonest).</time_frame>
    <description>Distance measurements on the foot / lower leg of the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circumference and &quot;figure of eight&quot;</measure>
    <time_frame>Within 3 months after patient recruitment or before the end of the study (whichever is soonest).</time_frame>
    <description>Lower leg / foot circumference and &quot;figure of eight&quot; measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of the lower leg/foot</measure>
    <time_frame>Within 3 months after patient recruitment or before the end of the study (whichever is soonest).</time_frame>
    <description>As measured using the water displacement method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical grading of oedema</measure>
    <time_frame>Within 3 months after patient recruitment or before the end of the study (whichever is soonest).</time_frame>
    <description>Medical grading of peripheral oedema on a scale 1-5</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Heart Failure, Diastolic</condition>
  <condition>Edema Brain</condition>
  <condition>Decompensated Heartfailure</condition>
  <arm_group>
    <arm_group_label>20 outpatients with peripheral oedema</arm_group_label>
    <description>20 outpatients with clinically detectable peripheral oedema for 1 set of measurements.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20 cardiology controls</arm_group_label>
    <description>20 outpatients with heart failure without clinically detectable peripheral oedema (control group) for 1 set of measurements.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 in-patients peripheral oedema</arm_group_label>
    <description>10 in patients hospitalised as a result of heart failure and fluid congestion with peripheral oedema, those patients will have several sets of measurements taken over time to measure the reduction of peripheral oedema which is likely to show common features with the formation of peripheral oedema.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30 control without cardiac conditions</arm_group_label>
    <description>less than 30 normal controls (healthy volunteers and patients without heart failure) in the age group 55 and above who agree to have images taken using the Heartfelt-1 device (not the whole set of measurements).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Heartfelt-1</intervention_name>
    <description>The patients will stand in front of the Heartfelt-1 in order for images to be captured and the volume of their lower legs measured.</description>
    <arm_group_label>10 in-patients peripheral oedema</arm_group_label>
    <arm_group_label>20 cardiology controls</arm_group_label>
    <arm_group_label>20 outpatients with peripheral oedema</arm_group_label>
    <arm_group_label>30 control without cardiac conditions</arm_group_label>
    <other_name>HF-1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Weighing scales</intervention_name>
    <description>The patient will be asked to stand on standard medical weighing scales, to measure their weight.</description>
    <arm_group_label>10 in-patients peripheral oedema</arm_group_label>
    <arm_group_label>20 cardiology controls</arm_group_label>
    <arm_group_label>20 outpatients with peripheral oedema</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical grading of oedema</intervention_name>
    <description>A member of the research team will assess the severity of the peripheral oedema on a scale of 1-5.</description>
    <arm_group_label>10 in-patients peripheral oedema</arm_group_label>
    <arm_group_label>20 cardiology controls</arm_group_label>
    <arm_group_label>20 outpatients with peripheral oedema</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Baseline assessements</intervention_name>
    <description>At the point study participants are recruited, their age, sex, diagnosis, aetiology of heart failure, LVEF (Left ventricular ejection fraction), medical and device therapy, time since diagnosis, BNP (B-type Natriuretic Peptide), CRP (C-Reactive Protein), renal function (EGFR), Haemoglobin, albumin and urinalysis will be assessed unless recent (less that 6 months old) results are available. The number of Heart failure hospital admissions in the last 2 years, LACE score, co-morbidities will also be noted.</description>
    <arm_group_label>10 in-patients peripheral oedema</arm_group_label>
    <arm_group_label>20 cardiology controls</arm_group_label>
    <arm_group_label>20 outpatients with peripheral oedema</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Water displacement method</intervention_name>
    <description>This will involve filling a gauge with lukewarm water (27-35oC +-2oC) up to the appropriate level. The appropriate level is determined by the water stabilising after some has flown out of the gauge into the waste bucket. Once the water level is stable the patient, who is sitting on a chair will be gently plunging the foot (naked) in the gauge until their foot is flat on the bottom on the gauge. The water flowing out of the gauge into the measuring bucket will be collected until the flow of water stops. Four small marks with non-toxic /non-permanent pen will be made on the lower leg of the patient to indicate where the water level was at. The water which has been collected in the measuring bucket will be weighted with precision scales to determine the volume of water displaced by the insertion of the foot. The patient's foot will then be dried.</description>
    <arm_group_label>10 in-patients peripheral oedema</arm_group_label>
    <arm_group_label>20 cardiology controls</arm_group_label>
    <arm_group_label>20 outpatients with peripheral oedema</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Callipers measurements</intervention_name>
    <description>This will involve making 4 marks on one of the foot/lower leg (small cross) using non-toxic / non- permanent pen. The measurement will consist of making 6 measurements between those marks using callipers, and reporting the distance on a calibrated tape.</description>
    <arm_group_label>10 in-patients peripheral oedema</arm_group_label>
    <arm_group_label>20 cardiology controls</arm_group_label>
    <arm_group_label>20 outpatients with peripheral oedema</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Measuring tape</intervention_name>
    <description>The measurements taken using a medical tape measure will involve the circumference of the ankle to be measured as well as the circumference at the level of the arch of the foot. The medical tape used will be a CE marked disposable medical measuring tape to minimise the risk of infection. The measurements will be done on both feet.</description>
    <arm_group_label>10 in-patients peripheral oedema</arm_group_label>
    <arm_group_label>20 cardiology controls</arm_group_label>
    <arm_group_label>20 outpatients with peripheral oedema</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults able to give consent to take part in the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inpatients with admission for de-compensated heart failure requiring increase or&#xD;
             initiation of diuretic therapy for fluid congestion.&#xD;
&#xD;
          -  Patients attending cardiology outpatients at the Royal Brompton hospital with a&#xD;
             diagnosis of heart failure and fluid retention.&#xD;
&#xD;
          -  Cardiology patient without fluid retention (cardiology controls) Non-Cardiology&#xD;
             patient without fluid retention (controls)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to provide informed consent.&#xD;
&#xD;
          -  Unstable arrhythmias in previous 48 hours&#xD;
&#xD;
          -  Systolic BP&lt;90mmHg or need for inotropic support&#xD;
&#xD;
          -  Ulceration on lower limbs (below shin) - excluded from water displacement but could&#xD;
             have image recording and calipers&#xD;
&#xD;
          -  Inability to transfer from bed to chair&#xD;
&#xD;
          -  Patients with broken skin or cellulitis will not have their foot volume measured using&#xD;
             the water displacement equipment to reduce the risk of infection for the patient and&#xD;
             other participants.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander Lyon, BCh PhD FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Brompton and Harefield NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Brompton Hospital</name>
      <address>
        <city>London</city>
        <zip>SW3 6NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Chausiaux O, Williams G, Nieznanski M, Bagdu A, Downer P, Keyser M, Husheer S. Evaluation of the Accuracy of a Video and AI Solution to Measure Lower Leg and Foot Volume. Med Devices (Auckl). 2021 Apr 13;14:105-118. doi: 10.2147/MDER.S297713. eCollection 2021.</citation>
    <PMID>33880069</PMID>
  </results_reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>October 5, 2021</last_update_submitted>
  <last_update_submitted_qc>October 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <keyword>Edema</keyword>
  <keyword>Oedema</keyword>
  <keyword>Decompensated Heartfailure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Heart Failure, Diastolic</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We are not planning to share individual participant data with other researchers.</ipd_description>
  </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/NCT02993601
org study id: RBH01
nct id: NCT02993601
lead sponsor: 
collaborator: 
has dmc: No
The study aims at assessing the usefulness of the Heartfelt1 device in patients suffering
      from heart failure, who have peripheral oedema. The device is non-contact and does not
      requires patient compliance to work. It gives an output reading of the patient's lower leg
      volume.

      During the study, this measurement will be compared to clinical standard and gold standard
      measurements as well as clinical grading of peripheral oedema.
The Heartfelt-1 device is a CE (Conformité Européenne = European Conformity) mark medical
      device used to measure biometric parameters of the foot and lower leg. The study aims at
      assessing the usefulness in patients suffering from heart failure, who have peripheral
      oedema. Models used for the measurements of foot and lower legs have not yet been validated
      for this group of patients, who are likely to have feet with abnormal surface contours and
      appearance secondary to oedema. Peripheral oedema can be a leading indicator of heart failure
      de-compensation which can lead to hospitalisation of patients, and therefore the device could
      be a useful clinical tool to monitor patients in their home. The Heartfelt-1 device has the
      ability to recognise the patient's feet (amongst an average size household setting), and
      trigger automatically the measurements when the feet are naked (for example as the patient
      goes in and out of bed). This makes the device an obvious choice for patients with compliance
      issues with current methods of monitoring (e.g. daily use of weighing scales) and treatment
      (e.g. diuretics) if it could be validated in this patient group.

      The study has two general aims:

      The first is to collect a time-series of data on inpatients with peripheral oedema caused by
      heart failure, as they receive intravenous or oral diuretic treatment to remove excess fluid
      and achieve optimal body weight and fluid balance. This data will be used both to determine
      the attainable resolution of foot biometric measurements on a patient as their fluid status
      changes, and also to further develop the algorithms used in the device and make them usable
      on a wide range of feet/lower legs which have been deformed by oedema. The data required for
      this study are images taken using the Heartfelt-1 device, as well as validation measurements
      such as the figure of eight using a medical grade tape measure, callipers, or the water
      displacement method using a volumetric gauge, at multiple time-points whilst the peripheral
      oedema reduces.

      The second, on a second group of stable ambulatory (Heart Failure) HF patients with variable
      levels of oedema, is to evaluate the performance of the Heartfelt-1 device in determining
      foot biometric parameters one a wide range of patients at a single point in time. Patients
      with stable chronic heart failure will have their foot/lower legs measured by the Heartfelt-1
      device, as well as standard medical measurement (figure of eight using a medical grade tape
      measure, callipers) and gold standard measurement (water displacement method using a gauge),
      as well as the patient's weight and a clinical grading of oedema. These will be compared and
      an estimate of the accuracy of the Heartfelt-1 device over this wider patient group can be
      extrapolated.
observational model: Case-Control
time perspective: Prospective
measure: Volume as measured by the Heartfelt-1 device
time frame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
measure: Weight
time frame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
description: Patient weight on the day
measure: Distance measurements
time frame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
description: Distance measurements on the foot / lower leg of the patient
measure: Circumference and "figure of eight"
time frame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
description: Lower leg / foot circumference and "figure of eight" measurement
measure: Volume of the lower leg/foot
time frame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
description: As measured using the water displacement method.
measure: Medical grading of oedema
time frame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
description: Medical grading of peripheral oedema on a scale 1-5
arm group label: 20 outpatients with peripheral oedema
description: 20 outpatients with clinically detectable peripheral oedema for 1 set of measurements.
arm group label: 20 cardiology controls
description: 20 outpatients with heart failure without clinically detectable peripheral oedema (control group) for 1 set of measurements.
arm group label: 10 in-patients peripheral oedema
description: 10 in patients hospitalised as a result of heart failure and fluid congestion with peripheral oedema, those patients will have several sets of measurements taken over time to measure the reduction of peripheral oedema which is likely to show common features with the formation of peripheral oedema.
arm group label: 30 control without cardiac conditions
description: less than 30 normal controls (healthy volunteers and patients without heart failure) in the age group 55 and above who agree to have images taken using the Heartfelt-1 device (not the whole set of measurements).
intervention type: Device
intervention name: Heartfelt-1
description: The patients will stand in front of the Heartfelt-1 in order for images to be captured and the volume of their lower legs measured.
arm group label: 10 in-patients peripheral oedema
arm group label: 20 cardiology controls
arm group label: 20 outpatients with peripheral oedema
arm group label: 30 control without cardiac conditions
other name: HF-1
intervention type: Device
intervention name: Weighing scales
description: The patient will be asked to stand on standard medical weighing scales, to measure their weight.
arm group label: 10 in-patients peripheral oedema
arm group label: 20 cardiology controls
arm group label: 20 outpatients with peripheral oedema
intervention type: Other
intervention name: Medical grading of oedema
description: A member of the research team will assess the severity of the peripheral oedema on a scale of 1-5.
arm group label: 10 in-patients peripheral oedema
arm group label: 20 cardiology controls
arm group label: 20 outpatients with peripheral oedema
intervention type: Other
intervention name: Baseline assessements
description: At the point study participants are recruited, their age, sex, diagnosis, aetiology of heart failure, LVEF (Left ventricular ejection fraction), medical and device therapy, time since diagnosis, BNP (B-type Natriuretic Peptide), CRP (C-Reactive Protein), renal function (EGFR), Haemoglobin, albumin and urinalysis will be assessed unless recent (less that 6 months old) results are available. The number of Heart failure hospital admissions in the last 2 years, LACE score, co-morbidities will also be noted.
arm group label: 10 in-patients peripheral oedema
arm group label: 20 cardiology controls
arm group label: 20 outpatients with peripheral oedema
intervention type: Device
intervention name: Water displacement method
description: This will involve filling a gauge with lukewarm water (27-35oC +-2oC) up to the appropriate level. The appropriate level is determined by the water stabilising after some has flown out of the gauge into the waste bucket. Once the water level is stable the patient, who is sitting on a chair will be gently plunging the foot (naked) in the gauge until their foot is flat on the bottom on the gauge. The water flowing out of the gauge into the measuring bucket will be collected until the flow of water stops. Four small marks with non-toxic /non-permanent pen will be made on the lower leg of the patient to indicate where the water level was at. The water which has been collected in the measuring bucket will be weighted with precision scales to determine the volume of water displaced by the insertion of the foot. The patient's foot will then be dried.
arm group label: 10 in-patients peripheral oedema
arm group label: 20 cardiology controls
arm group label: 20 outpatients with peripheral oedema
intervention type: Device
intervention name: Callipers measurements
description: This will involve making 4 marks on one of the foot/lower leg (small cross) using non-toxic / non- permanent pen. The measurement will consist of making 6 measurements between those marks using callipers, and reporting the distance on a calibrated tape.
arm group label: 10 in-patients peripheral oedema
arm group label: 20 cardiology controls
arm group label: 20 outpatients with peripheral oedema
intervention type: Device
intervention name: Measuring tape
description: The measurements taken using a medical tape measure will involve the circumference of the ankle to be measured as well as the circumference at the level of the arch of the foot. The medical tape used will be a CE marked disposable medical measuring tape to minimise the risk of infection. The measurements will be done on both feet.
arm group label: 10 in-patients peripheral oedema
arm group label: 20 cardiology controls
arm group label: 20 outpatients with peripheral oedema
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alexander Lyon, BCh PhD FRCP
role: Principal Investigator
affiliation: Royal Brompton and Harefield NHS Foundation Trust
facility: 
country: United Kingdom
citation: Chausiaux O, Williams G, Nieznanski M, Bagdu A, Downer P, Keyser M, Husheer S. Evaluation of the Accuracy of a Video and AI Solution to Measure Lower Leg and Foot Volume. Med Devices (Auckl). 2021 Apr 13;14:105-118. doi: 10.2147/MDER.S297713. eCollection 2021.
PMID: 33880069
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Heart Failure, Diastolic
mesh term: Edema
sharing ipd: No
ipd description: We are not planning to share individual participant data with other researchers.