<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/NCT04451356</url>
  </required_header>
  <id_info>
    <org_study_id>UMF</org_study_id>
    <nct_id>NCT04451356</nct_id>
  </id_info>
  <brief_title>Romanian Kidney Transplant Cardiovascular Risk Registry</brief_title>
  <acronym>ROKET-CV</acronym>
  <official_title>The Complex Evaluation of the Cardiovascular Risk in the Kidney Transplant Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grigore T. Popa University of Medicine and Pharmacy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Grigore T. Popa University of Medicine and Pharmacy</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>
      Kidney transplantation (KT) represents the best treatment for patients with end-stage kidney&#xD;
      disease, being associated with improved outcomes and reduced mortality. Although the survival&#xD;
      benefit with KT is mostly attributable to reduction in cardiovascular (CV) disease, KT&#xD;
      recipients continue to remain at higher risk for CV-related morbidity and mortality when&#xD;
      compared with the general population. Additionally, CV events represent the leading cause of&#xD;
      death in KT recipients with a functioning allograft. KT recipients have high rates of&#xD;
      hospitalization for myocardial infarction, congestive heart failure, dysrhythmias, stroke,&#xD;
      malignant hypertension, and cardiac arrest. Significant amounts of research have been aimed&#xD;
      at reducing event rates, primarily aimed at understanding prevalent risk factors, defining&#xD;
      outcomes, and application of guideline-based care.&#xD;
&#xD;
      The post-KT milieu represents the confluence of several traditional and nontraditional CV&#xD;
      risk factors contributing to the significant CV risk in this population. CV disease remains&#xD;
      an understudied and undertreated source of morbidity and mortality in KT patients. Patients&#xD;
      with chronic kidney disease (CKD) are generally excluded from major cardiovascular outcome&#xD;
      trials, and this phenomenon of aversion to including patients with CKD in CV trials and&#xD;
      providing appropriate goal-directed medical and interventional therapies (renalism) extends&#xD;
      into KT .&#xD;
&#xD;
      The main aim of this study is to evaluate holistically the CV risk in a KT population. The&#xD;
      investigators will compare bioimpedance spectroscopy derived fluid status parameters&#xD;
      (overhydration, total body water, extracellular water and intracellular water) with clinical&#xD;
      evaluation, lung ultrasonography, pulse wave velocity, different biomarkers, and&#xD;
      echocardiographic characteristics and also to determine the impact of these parameters on&#xD;
      renal and CV outcomes in the same population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      • Patients:&#xD;
&#xD;
      The inclusion criteria are:&#xD;
&#xD;
        1. age&gt;18 years;&#xD;
&#xD;
        2. KT recipient.&#xD;
&#xD;
      The exclusion criteria are:&#xD;
&#xD;
        1. metallic joint prostheses, cardiac stent or pacemakers, decompensated cirrhosis,&#xD;
           pregnancy and limb amputations (due to bioimpedance technique limitations);&#xD;
&#xD;
        2. no prior diagnosis of pulmonary fibrosis, pneumectomy or massive pleural effusion (due&#xD;
           to lung ultrasonography limitations);&#xD;
&#xD;
        3. active systemic infections (due to difficulties in the interpretation of nespecific&#xD;
           inflammation biomarkers in this type of patients);&#xD;
&#xD;
        4. absence of congenital heart disease;&#xD;
&#xD;
        5. eGFR below 30 ml/min/1.73m2;&#xD;
&#xD;
        6. KT vintage of at least 6 months.&#xD;
&#xD;
             -  Methods:&#xD;
&#xD;
      All patients will have a complete clinical and paraclinical evaluation:&#xD;
&#xD;
        -  Personal data (age, sex, height);&#xD;
&#xD;
        -  Cardiovascular risk factors (smoking, weight, body mass index);&#xD;
&#xD;
        -  Medication (including immunosupression);&#xD;
&#xD;
        -  Kidney transplantation data (date of transplantation, type - living or cadaveric donor,&#xD;
           missmatch number, type of induction therapy);&#xD;
&#xD;
        -  Dialysis vintage (before KT)&#xD;
&#xD;
        -  Comorbidities (diabetes, hypertension, stroke, coronary artery disease, etc);&#xD;
&#xD;
        -  Physical examination (blood pressure, crackles, pedal edema etc);&#xD;
&#xD;
        -  Renal function evaluation (serum urea and creatinine, serum electrolytes - K, Na, Cl)&#xD;
&#xD;
        -  Nutrition status evaluation: serum protein, cholesterol, triglycerides;&#xD;
&#xD;
        -  Inflammation evaluation: CRP;&#xD;
&#xD;
        -  Serum glucose and uric acid;&#xD;
&#xD;
        -  Hemoleucogram;&#xD;
&#xD;
        -  Electrocardiogram.&#xD;
&#xD;
      Bioimpedance spectroscopy analysis This analysis will be performed at baseline using the&#xD;
      portable whole-body multifrequency bioimpedance analysis device (BCM®Body Composition Monitor&#xD;
      - Fresenius Medical Care D GmbH). The technique involves attaching electrodes to the&#xD;
      patient's forearm and ipsilateral ankle, with the patient in a supine position. The BCM®&#xD;
      measures the body resistance and reactance to electrical currents of 50 discrete frequencies,&#xD;
      ranging between 5 and 1000 kHz. Based on a fluid model using these resistances, the&#xD;
      extracellular water (ECW), the intracellular water (ICW) and the total body water (TBW) are&#xD;
      calculated. These volumes are then used to determine the amount of fluid overload. All&#xD;
      calculations are automatically performed by the software of the BCM® device. Absolute fluid&#xD;
      overload (AFO) is is defined as the difference between the expected patient's ECW under&#xD;
      normal physiological conditions and the actual ECW, whereas the relative fluid overload (RFO)&#xD;
      is defined as the absolute fluid overload AFO to ECW ratio. Normohydration is defined when&#xD;
      AFO is between the 10th and the 90th percentile for healthy, age- and gender-matched&#xD;
      individuals from the reference population, i.e. between -1.1 to +1.1 L, while volumes below&#xD;
      and above this range defining underhydration and overhydration, respectively. In addition,&#xD;
      this analysis will provide the LTI and FTI for the included patients.&#xD;
&#xD;
      Echocardiography Echocardiographic evaluations will be made in each patient at baseline. All&#xD;
      echocardiographic measurements will be carried out according to the recommendations of the&#xD;
      American Society of Echocardiography by an observer unaware of the lung ultrasound and&#xD;
      bioimpedance results. Echocardiographic evaluation will provide information about cardiac&#xD;
      anatomy (e.g. volumes, geometry, mass) and function (e.g. left ventricular function and wall&#xD;
      motion, valvular function, right ventricular function, pulmonary artery pressure,&#xD;
      pericardium).&#xD;
&#xD;
      Lung ultrasonography Examinations will be performed in the supine position. Scanning of the&#xD;
      anterior and lateral chest will be performed on both sides of the chest, from the second to&#xD;
      the fourth (on the right side to the fifth) intercostal spaces, at parasternal to&#xD;
      mid-axillary lines. B-lines will be recorded in each intercostal space and were defined as a&#xD;
      hyperechoic, coherent US bundle at narrow basis going from the transducer to the limit of the&#xD;
      screen. B-lines starting from the pleural line can be either localized or scattered to the&#xD;
      whole lung and be present as isolated or multiple artifacts. The sum of B-lines produces a&#xD;
      score reflecting the extent of lung water accumulation (0 being no detectable B-line).&#xD;
&#xD;
      Arterial stiffness Arterial stiffness assessment will be performed by applanation tonometry&#xD;
      (SphygmoCorTM; PWV Inc., Westmead, Sydney, Australia) with the patient being recumbent, 10&#xD;
      minutes before the measures were done. The carotid and femoral pulse will be acquired by&#xD;
      applanation tonometry sequentially, allowing a single operator to acquire the measurement.&#xD;
      The transit time from the R-wave of the simultaneously acquired electrocardiogram to the foot&#xD;
      of the carotid and femoral pulse is measured. The difference acquired electrocardiogram to&#xD;
      the foot of the carotid and femoral pulse is measured. The difference between these 2 transit&#xD;
      times is divided by distances measured from the body surface to estimate the arterial path&#xD;
      length in order to calculate carotid-femoral PWV. The SphygmoCor PWV has been established in&#xD;
      the literature as a reference for comparison due to the wealth of population data and healthy&#xD;
      population refence values. The investigators will determine two PWVs for every patient and&#xD;
      use the media for the statistical analysis. If the difference between these two measurements&#xD;
      will be higher than 0.5 m/s then another determination will be performed and the median will&#xD;
      be used for analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>36 Months</target_duration>
  <primary_outcome>
    <measure>Composite Renal Outcome</measure>
    <time_frame>36 months</time_frame>
    <description>Doubling of creatinine or dialysis initiation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite Cardiovascular Outcome</measure>
    <time_frame>36 months</time_frame>
    <description>Time to first non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, or cardiovascular death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chronic kidney disease progression</measure>
    <time_frame>36 months</time_frame>
    <description>The impact of baseline characteristics on eGFR (as assessed by the CKD-EPI formula) evolution</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proteinuria progression</measure>
    <time_frame>36 months</time_frame>
    <description>The impact of baseline characteristics on proteinuria (as assessed by the urine protein to creatinine ratio) evolution</description>
  </secondary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Kidney Transplant; Complications</condition>
  <condition>Cardiovascular Diseases</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bioimpedance Spectroscopy</intervention_name>
    <description>This analysis will be performed at baseline using the portable whole-body multifrequency bioimpedance analysis device (BCM®Body Composition Monitor - Fresenius Medical Care D GmbH). The technique involves attaching electrodes to the patient's forearm and ipsilateral ankle, with the patient in a supine position. The BCM® measures the body resistance and reactance to electrical currents of 50 discrete frequencies, ranging between 5 and 1000 kHz. Based on a fluid model using these resistances, the extracellular water (ECW), the intracellular water (ICW) and the total body water (TBW) are calculated. These volumes are then used to determine the amount of fluid overload. All calculations are automatically performed by the software of the BCM® device. In addition, this analysis will provide the LTI and FTI for the included patients.</description>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Arterial Stiffness</intervention_name>
    <description>Arterial stiffness assessment will be performed by applanation tonometry (SphygmoCorTM; PWV Inc., Westmead, Sydney, Australia) with the patient being recumbent, 10 minutes before the measures were done. The carotid and femoral pulse will be acquired by applanation tonometry sequentially, allowing a single operator to acquire the measurement. The transit time from the R-wave of the simultaneously acquired electrocardiogram to the foot of the carotid and femoral pulse is measured. The difference acquired electrocardiogram to the foot of the carotid and femoral pulse is measured. The difference between these 2 transit times is divided by distances measured from the body surface to estimate the arterial path length in order to calculate carotid-femoral PWV.</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Echocardiography</intervention_name>
    <description>Echocardiographic evaluations will be made in each patient at baseline. All echocardiographic measurements will be carried out according to the recommendations of the American Society of Echocardiography by an observer unaware of the lung ultrasound and bioimpedance results. Echocardiographic evaluation will provide information about cardiac anatomy (e.g. volumes, geometry, mass) and function (e.g. left ventricular function and wall motion, valvular function, right ventricular function, pulmonary artery pressure, pericardium).</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Lung ultrasonography</intervention_name>
    <description>Examinations will be performed in the supine position. Scanning of the anterior and lateral chest will be performed on both sides of the chest, from the second to the fourth (on the right side to the fifth) intercostal spaces, at parasternal to mid-axillary lines. B-lines will be recorded in each intercostal space and were defined as a hyperechoic, coherent US bundle at narrow basis going from the transducer to the limit of the screen. B-lines starting from the pleural line can be either localized or scattered to the whole lung and be present as isolated or multiple artifacts. The sum of B-lines produces a score reflecting the extent of lung water accumulation (0 being no detectable B-line).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Kidney Transplant Recipients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age&gt;18 years;&#xD;
&#xD;
          2. Kidney Transplant Recipient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. metallic joint prostheses, cardiac stent or pacemakers, decompensated cirrhosis,&#xD;
             pregnancy and limb amputations (due to bioimpedance technique limitations);&#xD;
&#xD;
          2. no prior diagnosis of pulmonary fibrosis, pneumectomy or massive pleural effusion (due&#xD;
             to lung ultrasonography limitations);&#xD;
&#xD;
          3. active systemic infections (due to difficulties in the interpretation of nespecific&#xD;
             inflammation biomarkers in this type of patients);&#xD;
&#xD;
          4. absence of congenital heart disease;&#xD;
&#xD;
          5. eGFR below 30 ml/min/1.73m2;&#xD;
&#xD;
          6. KT vintage of at least 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adrian Covic, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Grigore T. Popa University of Medicine and Pharmacy, Iasi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dimitrie Siriopol</last_name>
    <phone>+40740138874</phone>
    <email>dimitrie.siriopol@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>&quot;Dr. C.I. Parhon&quot; Hospital</name>
      <address>
        <city>Iasi</city>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dimitrie Siriopol</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>October 8, 2019</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Grigore T. Popa University of Medicine and Pharmacy</investigator_affiliation>
    <investigator_full_name>Dimitrie Siriopol</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Kidney Transplant</keyword>
  <keyword>Bioimpedance Spectroscopy</keyword>
  <keyword>Arterial stiffness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04451356
org study id: UMF
nct id: NCT04451356
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Kidney transplantation (KT) represents the best treatment for patients with end-stage kidney
      disease, being associated with improved outcomes and reduced mortality. Although the survival
      benefit with KT is mostly attributable to reduction in cardiovascular (CV) disease, KT
      recipients continue to remain at higher risk for CV-related morbidity and mortality when
      compared with the general population. Additionally, CV events represent the leading cause of
      death in KT recipients with a functioning allograft. KT recipients have high rates of
      hospitalization for myocardial infarction, congestive heart failure, dysrhythmias, stroke,
      malignant hypertension, and cardiac arrest. Significant amounts of research have been aimed
      at reducing event rates, primarily aimed at understanding prevalent risk factors, defining
      outcomes, and application of guideline-based care.

      The post-KT milieu represents the confluence of several traditional and nontraditional CV
      risk factors contributing to the significant CV risk in this population. CV disease remains
      an understudied and undertreated source of morbidity and mortality in KT patients. Patients
      with chronic kidney disease (CKD) are generally excluded from major cardiovascular outcome
      trials, and this phenomenon of aversion to including patients with CKD in CV trials and
      providing appropriate goal-directed medical and interventional therapies (renalism) extends
      into KT .

      The main aim of this study is to evaluate holistically the CV risk in a KT population. The
      investigators will compare bioimpedance spectroscopy derived fluid status parameters
      (overhydration, total body water, extracellular water and intracellular water) with clinical
      evaluation, lung ultrasonography, pulse wave velocity, different biomarkers, and
      echocardiographic characteristics and also to determine the impact of these parameters on
      renal and CV outcomes in the same population.
• Patients:

      The inclusion criteria are:

        1. age>18 years;

        2. KT recipient.

      The exclusion criteria are:

        1. metallic joint prostheses, cardiac stent or pacemakers, decompensated cirrhosis,
           pregnancy and limb amputations (due to bioimpedance technique limitations);

        2. no prior diagnosis of pulmonary fibrosis, pneumectomy or massive pleural effusion (due
           to lung ultrasonography limitations);

        3. active systemic infections (due to difficulties in the interpretation of nespecific
           inflammation biomarkers in this type of patients);

        4. absence of congenital heart disease;

        5. eGFR below 30 ml/min/1.73m2;

        6. KT vintage of at least 6 months.

             -  Methods:

      All patients will have a complete clinical and paraclinical evaluation:

        -  Personal data (age, sex, height);

        -  Cardiovascular risk factors (smoking, weight, body mass index);

        -  Medication (including immunosupression);

        -  Kidney transplantation data (date of transplantation, type - living or cadaveric donor,
           missmatch number, type of induction therapy);

        -  Dialysis vintage (before KT)

        -  Comorbidities (diabetes, hypertension, stroke, coronary artery disease, etc);

        -  Physical examination (blood pressure, crackles, pedal edema etc);

        -  Renal function evaluation (serum urea and creatinine, serum electrolytes - K, Na, Cl)

        -  Nutrition status evaluation: serum protein, cholesterol, triglycerides;

        -  Inflammation evaluation: CRP;

        -  Serum glucose and uric acid;

        -  Hemoleucogram;

        -  Electrocardiogram.

      Bioimpedance spectroscopy analysis This analysis will be performed at baseline using the
      portable whole-body multifrequency bioimpedance analysis device (BCM®Body Composition Monitor
      - Fresenius Medical Care D GmbH). The technique involves attaching electrodes to the
      patient's forearm and ipsilateral ankle, with the patient in a supine position. The BCM®
      measures the body resistance and reactance to electrical currents of 50 discrete frequencies,
      ranging between 5 and 1000 kHz. Based on a fluid model using these resistances, the
      extracellular water (ECW), the intracellular water (ICW) and the total body water (TBW) are
      calculated. These volumes are then used to determine the amount of fluid overload. All
      calculations are automatically performed by the software of the BCM® device. Absolute fluid
      overload (AFO) is is defined as the difference between the expected patient's ECW under
      normal physiological conditions and the actual ECW, whereas the relative fluid overload (RFO)
      is defined as the absolute fluid overload AFO to ECW ratio. Normohydration is defined when
      AFO is between the 10th and the 90th percentile for healthy, age- and gender-matched
      individuals from the reference population, i.e. between -1.1 to +1.1 L, while volumes below
      and above this range defining underhydration and overhydration, respectively. In addition,
      this analysis will provide the LTI and FTI for the included patients.

      Echocardiography Echocardiographic evaluations will be made in each patient at baseline. All
      echocardiographic measurements will be carried out according to the recommendations of the
      American Society of Echocardiography by an observer unaware of the lung ultrasound and
      bioimpedance results. Echocardiographic evaluation will provide information about cardiac
      anatomy (e.g. volumes, geometry, mass) and function (e.g. left ventricular function and wall
      motion, valvular function, right ventricular function, pulmonary artery pressure,
      pericardium).

      Lung ultrasonography Examinations will be performed in the supine position. Scanning of the
      anterior and lateral chest will be performed on both sides of the chest, from the second to
      the fourth (on the right side to the fifth) intercostal spaces, at parasternal to
      mid-axillary lines. B-lines will be recorded in each intercostal space and were defined as a
      hyperechoic, coherent US bundle at narrow basis going from the transducer to the limit of the
      screen. B-lines starting from the pleural line can be either localized or scattered to the
      whole lung and be present as isolated or multiple artifacts. The sum of B-lines produces a
      score reflecting the extent of lung water accumulation (0 being no detectable B-line).

      Arterial stiffness Arterial stiffness assessment will be performed by applanation tonometry
      (SphygmoCorTM; PWV Inc., Westmead, Sydney, Australia) with the patient being recumbent, 10
      minutes before the measures were done. The carotid and femoral pulse will be acquired by
      applanation tonometry sequentially, allowing a single operator to acquire the measurement.
      The transit time from the R-wave of the simultaneously acquired electrocardiogram to the foot
      of the carotid and femoral pulse is measured. The difference acquired electrocardiogram to
      the foot of the carotid and femoral pulse is measured. The difference between these 2 transit
      times is divided by distances measured from the body surface to estimate the arterial path
      length in order to calculate carotid-femoral PWV. The SphygmoCor PWV has been established in
      the literature as a reference for comparison due to the wealth of population data and healthy
      population refence values. The investigators will determine two PWVs for every patient and
      use the media for the statistical analysis. If the difference between these two measurements
      will be higher than 0.5 m/s then another determination will be performed and the median will
      be used for analysis.
observational model: Cohort
time perspective: Prospective
measure: Composite Renal Outcome
time frame: 36 months
description: Doubling of creatinine or dialysis initiation.
measure: Composite Cardiovascular Outcome
time frame: 36 months
description: Time to first non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, or cardiovascular death
measure: Chronic kidney disease progression
time frame: 36 months
description: The impact of baseline characteristics on eGFR (as assessed by the CKD-EPI formula) evolution
measure: Proteinuria progression
time frame: 36 months
description: The impact of baseline characteristics on proteinuria (as assessed by the urine protein to creatinine ratio) evolution
intervention type: Device
intervention name: Bioimpedance Spectroscopy
description: This analysis will be performed at baseline using the portable whole-body multifrequency bioimpedance analysis device (BCM®Body Composition Monitor - Fresenius Medical Care D GmbH). The technique involves attaching electrodes to the patient's forearm and ipsilateral ankle, with the patient in a supine position. The BCM® measures the body resistance and reactance to electrical currents of 50 discrete frequencies, ranging between 5 and 1000 kHz. Based on a fluid model using these resistances, the extracellular water (ECW), the intracellular water (ICW) and the total body water (TBW) are calculated. These volumes are then used to determine the amount of fluid overload. All calculations are automatically performed by the software of the BCM® device. In addition, this analysis will provide the LTI and FTI for the included patients.
intervention type: Device
intervention name: Arterial Stiffness
description: Arterial stiffness assessment will be performed by applanation tonometry (SphygmoCorTM; PWV Inc., Westmead, Sydney, Australia) with the patient being recumbent, 10 minutes before the measures were done. The carotid and femoral pulse will be acquired by applanation tonometry sequentially, allowing a single operator to acquire the measurement. The transit time from the R-wave of the simultaneously acquired electrocardiogram to the foot of the carotid and femoral pulse is measured. The difference acquired electrocardiogram to the foot of the carotid and femoral pulse is measured. The difference between these 2 transit times is divided by distances measured from the body surface to estimate the arterial path length in order to calculate carotid-femoral PWV.
intervention type: Diagnostic Test
intervention name: Echocardiography
description: Echocardiographic evaluations will be made in each patient at baseline. All echocardiographic measurements will be carried out according to the recommendations of the American Society of Echocardiography by an observer unaware of the lung ultrasound and bioimpedance results. Echocardiographic evaluation will provide information about cardiac anatomy (e.g. volumes, geometry, mass) and function (e.g. left ventricular function and wall motion, valvular function, right ventricular function, pulmonary artery pressure, pericardium).
intervention type: Diagnostic Test
intervention name: Lung ultrasonography
description: Examinations will be performed in the supine position. Scanning of the anterior and lateral chest will be performed on both sides of the chest, from the second to the fourth (on the right side to the fifth) intercostal spaces, at parasternal to mid-axillary lines. B-lines will be recorded in each intercostal space and were defined as a hyperechoic, coherent US bundle at narrow basis going from the transducer to the limit of the screen. B-lines starting from the pleural line can be either localized or scattered to the whole lung and be present as isolated or multiple artifacts. The sum of B-lines produces a score reflecting the extent of lung water accumulation (0 being no detectable B-line).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Adrian Covic, Prof
role: Study Chair
affiliation: Grigore T. Popa University of Medicine and Pharmacy, Iasi
last name: Dimitrie Siriopol
phone: +40740138874
email: dimitrie.siriopol@yahoo.com
facility: 
status: Recruiting
contact: 
country: Romania
responsible party type: Principal Investigator
investigator affiliation: Grigore T. Popa University of Medicine and Pharmacy
investigator full name: Dimitrie Siriopol
investigator title: Associate Professor
mesh term: Cardiovascular Diseases
sharing ipd: Undecided