<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/NCT03763045</url>
  </required_header>
  <id_info>
    <org_study_id>Med135</org_study_id>
    <nct_id>NCT03763045</nct_id>
  </id_info>
  <brief_title>Sildenafil in Hemodialysis Patients With Pulmonary Hypertension</brief_title>
  <official_title>Evaluation of the Effect of Sildenafil in Hemodialysis Patients With Pulmonary Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sildenafil is a phosphodiesterase inhibitor that can exert a nitric oxide-mediated&#xD;
      vasodilation effect, so it's considered one of the preferred agents especially in hypoxia&#xD;
      induced pulmonary hypertension, can achieve pulmonary vasodilation by enhancing sustained&#xD;
      levels of cyclic guanosine monophosphate (cGMP) and nitric oxide.&#xD;
&#xD;
      Despite the potential burden of pulmonary hypertension in hemodialysis patients, such agent&#xD;
      like sildenafil has limited studies about optimum dose, safety and long term efficacy in End&#xD;
      stage renal disease patients on hemodialysis with pulmonary hypertension&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1- To evaluate the effect of sildenafil on pulmonary artery pressure and right ventricular&#xD;
      function in hemodialysis patients with pulmonary hypertension.&#xD;
&#xD;
        1. Primary outcome:&#xD;
&#xD;
           ● Reduction in estimated Pulmonary Artery pressure value (ePAP) in mmHg via&#xD;
           transthoracic Doppler Echocardiography.&#xD;
&#xD;
        2. Secondary outcomes:&#xD;
&#xD;
             -  Detection of safety of sildenafil in hemodialysis patients.&#xD;
&#xD;
             -  Finding out sildenafil's optimum dose for hemodialysis patients with pulmonary&#xD;
                hypertension.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 2, 2018</start_date>
  <completion_date type="Anticipated">February 28, 2019</completion_date>
  <primary_completion_date type="Anticipated">February 16, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Sildenafil 25: Twenty hemodialysis patients will receive a dose of 25mg sildenafil daily for 3 months.&#xD;
Sildenafil 50: Twenty hemodialysis patients will receive a dose of 50mg sildenafil daily for 3 months.&#xD;
Placebo: Twenty hemodialysis patients will receive a placebo tablet daily for 3 months.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double Blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease in Pulmonary Artery Pressure</measure>
    <time_frame>3 months</time_frame>
    <description>Decrease in ePAP (mmHg) via Doppler echocardiography Systolic right ventricular (or pulmonary artery)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Transthoracic echocardiography</measure>
    <time_frame>3 months</time_frame>
    <description>Decrease in Estimated PASP (Pulmonary Artery Systolic Pressure) in (mmHg).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <condition>Hemodialysis Complication</condition>
  <arm_group>
    <arm_group_label>Sildenafil 25</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty hemodialysis patients will receive a dose of 25mg sildenafil daily for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sildenafil 50</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty hemodialysis patients will receive a dose of 50mg sildenafil daily for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Twenty hemodialysis patients will receive a placebo tablet daily for 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sildenafil</intervention_name>
    <description>Sildenafil 25 mg: Phosphodiesterase inhibitor to be taken once daily</description>
    <arm_group_label>Sildenafil 25</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sildenafil</intervention_name>
    <description>Sildenafil 50 mg: Phosphodiesterase inhibitor to be taken once daily</description>
    <arm_group_label>Sildenafil 50</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tablet.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age from 18-80 years old.&#xD;
&#xD;
          2. Patients on maintenance hemodialysis for more than six months receiving 3 sessions /&#xD;
             week using bicarbonate dialysate with a low flux filter and heparin as anticoagulant.&#xD;
&#xD;
          3. Estimated Pulmonary Artery Pressure (ePAP) ≥35 mmHg via Doppler echocardiography&#xD;
&#xD;
          4. Urea reduction ratio (URR) will be ≥ 60% for all patients.&#xD;
&#xD;
          5. Dry weight will be targeted in each case to achieve edema-free state.&#xD;
&#xD;
          6. Informed consent in accordance with the Declaration of Helsinki.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Current treatment of pulmonary hypertension (prostacyclin analogues, endothelin&#xD;
             receptor antagonists or phosphodiesterase inhibitors).&#xD;
&#xD;
             2-Heart diseases (congestive heart failure, ischemic heart disease, congenital heart&#xD;
             disease).&#xD;
&#xD;
             3- Lung diseases (chronic obstructive pulmonary disease, pulmonary thromboemboli or&#xD;
             tumor, interstitial lung diseases, sleep apnea, pulmonary fibrosis, Sarcoidosis).&#xD;
&#xD;
             4-Systemic diseases (scleroderma, systemic lupus erythematosus, portal hypertension).&#xD;
&#xD;
             5-Human immunodeficiency virus (HIV) infection. 6-History of hypersensitivity to&#xD;
             sildenafil. 7-Treatment with any drugs that may interact with sildenafil (Erythromycin&#xD;
             , Azoles, Saquinavir-CYP3A4 inhibitors- , Bosentan - CYP3A4 inducer-Nitrates ) 8-&#xD;
             Uncontrolled hypertension 9- Anemia with hemoglobin level &lt;10 g/dl&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tamer W Elsaid, MD</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor of Internal Medicine and Nephrology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ain Shams University Hospital</name>
      <address>
        <city>Cairo</city>
        <state>Abbasia</state>
        <zip>00202</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 1, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Abdelrahman Ali Elbraky</investigator_full_name>
    <investigator_title>Assistant lecturer of Internal Medicine and Nephrology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sildenafil Citrate</mesh_term>
  </intervention_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/NCT03763045
org study id: Med135
nct id: NCT03763045
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Sildenafil is a phosphodiesterase inhibitor that can exert a nitric oxide-mediated
      vasodilation effect, so it's considered one of the preferred agents especially in hypoxia
      induced pulmonary hypertension, can achieve pulmonary vasodilation by enhancing sustained
      levels of cyclic guanosine monophosphate (cGMP) and nitric oxide.

      Despite the potential burden of pulmonary hypertension in hemodialysis patients, such agent
      like sildenafil has limited studies about optimum dose, safety and long term efficacy in End
      stage renal disease patients on hemodialysis with pulmonary hypertension
1- To evaluate the effect of sildenafil on pulmonary artery pressure and right ventricular
      function in hemodialysis patients with pulmonary hypertension.

        1. Primary outcome:

           ● Reduction in estimated Pulmonary Artery pressure value (ePAP) in mmHg via
           transthoracic Doppler Echocardiography.

        2. Secondary outcomes:

             -  Detection of safety of sildenafil in hemodialysis patients.

             -  Finding out sildenafil's optimum dose for hemodialysis patients with pulmonary
                hypertension.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Sildenafil 25: Twenty hemodialysis patients will receive a dose of 25mg sildenafil daily for 3 months.
Sildenafil 50: Twenty hemodialysis patients will receive a dose of 50mg sildenafil daily for 3 months.
Placebo: Twenty hemodialysis patients will receive a placebo tablet daily for 3 months.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double Blinded
measure: Decrease in Pulmonary Artery Pressure
time frame: 3 months
description: Decrease in ePAP (mmHg) via Doppler echocardiography Systolic right ventricular (or pulmonary artery)
measure: Transthoracic echocardiography
time frame: 3 months
description: Decrease in Estimated PASP (Pulmonary Artery Systolic Pressure) in (mmHg).
arm group label: Sildenafil 25
arm group type: Experimental
description: Twenty hemodialysis patients will receive a dose of 25mg sildenafil daily for 3 months.
arm group label: Sildenafil 50
arm group type: Experimental
description: Twenty hemodialysis patients will receive a dose of 50mg sildenafil daily for 3 months.
arm group label: Placebo
arm group type: Placebo Comparator
description: Twenty hemodialysis patients will receive a placebo tablet daily for 3 months.
intervention type: Drug
intervention name: Sildenafil
description: Sildenafil 25 mg: Phosphodiesterase inhibitor to be taken once daily
arm group label: Sildenafil 25
intervention type: Drug
intervention name: Sildenafil
description: Sildenafil 50 mg: Phosphodiesterase inhibitor to be taken once daily
arm group label: Sildenafil 50
intervention type: Other
intervention name: Placebo
description: Placebo tablet.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Tamer W Elsaid, MD
role: Study Director
affiliation: Associate Professor of Internal Medicine and Nephrology
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Abdelrahman Ali Elbraky
investigator title: Assistant lecturer of Internal Medicine and Nephrology
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
mesh term: Sildenafil Citrate
sharing ipd: Undecided