xml: <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/NCT06029803</url>
    </required_header>
    <id_info>
      <org_study_id>2022-1715</org_study_id>
      <nct_id>NCT06029803</nct_id>
    </id_info>
    <brief_title>Antecubital Versus Femoral Approach for Adrenal Venous Sampling</brief_title>
    <acronym>AFAVS</acronym>
    <official_title>Antecubital Versus Femoral Approach for Adrenal Venous Sampling: A Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chinese Academy of Medical Sciences, Fuwai Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Subtype diagnosis is crucial for the treatment of primary aldosteronism (PA), which conducts&#xD;
        the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the&#xD;
        gold standard for subtyping of PA. At present, almost all medical centers use the femoral&#xD;
        vein approach for AVS, and most studies report that the success rate is 30%-80%. Our research&#xD;
        team is the first in the world to conduct AVS via an antecubital approach. The aim of this&#xD;
        study is to compare the success rate and safety of AVS via antecubital and femoral approach.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary aldosteronism (PA) is one of the most common causes of secondary hypertension, and&#xD;
        its most common subtypes are aldosterone-producing adenoma and idiopathic hyperaldosteronism,&#xD;
        which account for 95% to 98% of PA. Subtype diagnosis is crucial for the treatment of primary&#xD;
        aldosteronism, which conducts the appropriate treatment strategy. Currently, adrenal venous&#xD;
        sampling (AVS) serves as the gold standard for subtyping of PA. At present, almost all&#xD;
        medical centers use the femoral vein approach for AVS, and most studies report that the&#xD;
        success rate is 30%-80%.How to improve the success rate of AVS has been a hot topic in the&#xD;
        field of primary aldosteronism. Our research team is the first in the world to conduct AVS&#xD;
        via an antecubital approach. The previous study found that the success rate of AVS via this&#xD;
        approach can reach to 88.0%, with a low incidence of complications. In this study, patients&#xD;
        with primary aldosteronism who meet the indications of AVS will be randomly assigned to&#xD;
        antecubital approach group and femoral approach group. Clinical, laboratory and examination&#xD;
        data will be recorded and the success rate and safety of AVS via antecubital and femoral&#xD;
        approach will be compared.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2022</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>N/A</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>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The success rate of bilateral adrenal venous sampling</measure>
      <time_frame>At AVS procedure</time_frame>
      <description>Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava &gt;2 without ACTH simulation)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The success rate of left adrenal venous sampling</measure>
      <time_frame>At AVS procedure</time_frame>
      <description>Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava &gt;2 without ACTH simulation)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The success rate of right adrenal venous sampling</measure>
      <time_frame>At AVS procedure</time_frame>
      <description>Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava &gt;2 without ACTH simulation)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Selection of intraoperative catheter</measure>
      <time_frame>At AVS procedure</time_frame>
      <description>Catheter selection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time of the procedure</measure>
      <time_frame>At AVS procedure</time_frame>
      <description>Time of the procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time of fluoroscopy</measure>
      <time_frame>At AVS procedure</time_frame>
      <description>Time of fluoroscopy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The contrast agent dosage</measure>
      <time_frame>At AVS procedure</time_frame>
      <description>The contrast agent dosage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the incidence of complications</measure>
      <time_frame>1 week after AVS procedure</time_frame>
      <description>Complications related to adrenal vein cannulations (adrenal vein hematoma, inferior vena cava dissection, puncture site hematoma, etc)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the cost of the procedure</measure>
      <time_frame>At AVS procedure</time_frame>
      <description>the cost of the procedure</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">154</enrollment>
    <condition>Hyperaldosteronism</condition>
    <arm_group>
      <arm_group_label>Adrenal Venous Sampling via Antecubital Approach</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in the experimental group will undergo adrenal venous sampling via antecubital vein approach.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Adrenal Venous Sampling via Femoral Approach</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients in the active comparator group will undergo adrenal venous sampling via femoral vein approach.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Adrenal Venous Sampling via Antecubital Approach</intervention_name>
      <description>Patients assigned to the antecubital approach group (experimental group) will undergo AVS via antecubital approach.A 5F introducer sheath will be introduced into the antecubital vein. After heparinization,a diagnostic catheter with side holes will be introduced. Two blood samples (about 4mL each) will be collected from the inferior vena cava, right adrenal vein and left adrenal vein for the determination of cortisol and aldosterone concentrations.</description>
      <arm_group_label>Adrenal Venous Sampling via Antecubital Approach</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Adrenal Venous Sampling via Femoral Approach</intervention_name>
      <description>Patients assigned to the femoral approach group (active comparator group) will undergo AVS via femoral vein approach.The introducer sheath will be introduced into the femoral vein.Two blood samples (about 4mL each) will be collected from the inferior vena cava, right adrenal vein and left adrenal vein for the determination of cortisol and aldosterone concentrations.</description>
      <arm_group_label>Adrenal Venous Sampling via Femoral Approach</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged from 18 to 60 with no limits in sex;&#xD;
  &#xD;
            2. Patients with confirmed primary aldosteronism;&#xD;
  &#xD;
            3. Patients or their legal representatives sign written informed consent approved by the&#xD;
               ethics committee&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Severe comorbidity, including stroke, myocardial infarction, heart failure, severe&#xD;
               valvular heart disease, liver cirrhosis, and metastatic tumor within the previous 3&#xD;
               months；&#xD;
  &#xD;
            2. An estimated glomerular filtration rate &lt;45 ml/min/1.73 m2, or serum creatinine &gt;176&#xD;
               μmol/L；&#xD;
  &#xD;
            3. Patients who refuse adrenalectomy;&#xD;
  &#xD;
            4. suspected of having an adrenocortical carcinoma;&#xD;
  &#xD;
            5. allergy to contrast agent;&#xD;
  &#xD;
            6. pregnant, nursing, or planning to become pregnant&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hui Dong, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hui Dong, MD</last_name>
      <phone>86-010-88322387</phone>
      <email>donghui666@sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100037</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hui Dong, MD</last_name>
        <phone>86-010-88322387</phone>
        <email>donghui666@sina.com</email>
      </contact>
      <investigator>
        <last_name>Hui Dong, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</investigator_affiliation>
      <investigator_full_name>Hui DONG</investigator_full_name>
      <investigator_title>professor</investigator_title>
    </responsible_party>
    <keyword>Adrenal venous sampling</keyword>
    <keyword>Hyperaldosteronism</keyword>
    <keyword>Antecubital approach</keyword>
    <keyword>Femoral approach</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyperaldosteronism</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Epinephrine</mesh_term>
      <mesh_term>Racepinephrine</mesh_term>
      <mesh_term>Epinephryl borate</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029803
  org study id: 2022-1715
  nct id: NCT06029803
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Subtype diagnosis is crucial for the treatment of primary aldosteronism (PA), which conducts
        the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the
        gold standard for subtyping of PA. At present, almost all medical centers use the femoral
        vein approach for AVS, and most studies report that the success rate is 30%-80%. Our research
        team is the first in the world to conduct AVS via an antecubital approach. The aim of this
        study is to compare the success rate and safety of AVS via antecubital and femoral approach.
  Primary aldosteronism (PA) is one of the most common causes of secondary hypertension, and
        its most common subtypes are aldosterone-producing adenoma and idiopathic hyperaldosteronism,
        which account for 95% to 98% of PA. Subtype diagnosis is crucial for the treatment of primary
        aldosteronism, which conducts the appropriate treatment strategy. Currently, adrenal venous
        sampling (AVS) serves as the gold standard for subtyping of PA. At present, almost all
        medical centers use the femoral vein approach for AVS, and most studies report that the
        success rate is 30%-80%.How to improve the success rate of AVS has been a hot topic in the
        field of primary aldosteronism. Our research team is the first in the world to conduct AVS
        via an antecubital approach. The previous study found that the success rate of AVS via this
        approach can reach to 88.0%, with a low incidence of complications. In this study, patients
        with primary aldosteronism who meet the indications of AVS will be randomly assigned to
        antecubital approach group and femoral approach group. Clinical, laboratory and examination
        data will be recorded and the success rate and safety of AVS via antecubital and femoral
        approach will be compared.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Single (Outcomes Assessor)
  measure: The success rate of bilateral adrenal venous sampling
  time frame: At AVS procedure
  description: Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava >2 without ACTH simulation)
  measure: The success rate of left adrenal venous sampling
  time frame: At AVS procedure
  description: Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava >2 without ACTH simulation)
  measure: The success rate of right adrenal venous sampling
  time frame: At AVS procedure
  description: Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava >2 without ACTH simulation)
  measure: Selection of intraoperative catheter
  time frame: At AVS procedure
  description: Catheter selection
  measure: Time of the procedure
  time frame: At AVS procedure
  description: Time of the procedure
  measure: Time of fluoroscopy
  time frame: At AVS procedure
  description: Time of fluoroscopy
  measure: The contrast agent dosage
  time frame: At AVS procedure
  description: The contrast agent dosage
  measure: the incidence of complications
  time frame: 1 week after AVS procedure
  description: Complications related to adrenal vein cannulations (adrenal vein hematoma, inferior vena cava dissection, puncture site hematoma, etc)
  measure: the cost of the procedure
  time frame: At AVS procedure
  description: the cost of the procedure
  arm group label: Adrenal Venous Sampling via Antecubital Approach
  arm group type: Experimental
  description: Patients in the experimental group will undergo adrenal venous sampling via antecubital vein approach.
  arm group label: Adrenal Venous Sampling via Femoral Approach
  arm group type: Active Comparator
  description: Patients in the active comparator group will undergo adrenal venous sampling via femoral vein approach.
  intervention type: Procedure
  intervention name: Adrenal Venous Sampling via Antecubital Approach
  description: Patients assigned to the antecubital approach group (experimental group) will undergo AVS via antecubital approach.A 5F introducer sheath will be introduced into the antecubital vein. After heparinization,a diagnostic catheter with side holes will be introduced. Two blood samples (about 4mL each) will be collected from the inferior vena cava, right adrenal vein and left adrenal vein for the determination of cortisol and aldosterone concentrations.
  arm group label: Adrenal Venous Sampling via Antecubital Approach
  intervention type: Procedure
  intervention name: Adrenal Venous Sampling via Femoral Approach
  description: Patients assigned to the femoral approach group (active comparator group) will undergo AVS via femoral vein approach.The introducer sheath will be introduced into the femoral vein.Two blood samples (about 4mL each) will be collected from the inferior vena cava, right adrenal vein and left adrenal vein for the determination of cortisol and aldosterone concentrations.
  arm group label: Adrenal Venous Sampling via Femoral Approach
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Hui Dong, MD
  role: Principal Investigator
  affiliation: Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
  last name: Hui Dong, MD
  phone: 86-010-88322387
  email: donghui666@sina.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
  investigator full name: Hui DONG
  investigator title: professor
  mesh term: Hyperaldosteronism
  mesh term: Epinephrine
  mesh term: Racepinephrine
  mesh term: Epinephryl borate