<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/NCT02253394</url>
  </required_header>
  <id_info>
    <org_study_id>CAPS_PAH</org_study_id>
    <nct_id>NCT02253394</nct_id>
  </id_info>
  <brief_title>The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study</brief_title>
  <official_title>The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (The CAPS-PAH Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out if spironolactone added to ambrisentan for Pulmonary&#xD;
      Arterial Hypertension (PAH) will increase exercise capacity. We also want to find out if&#xD;
      spironolactone and ambrisentan effect the cardiac output (amount of blood the heart pumps&#xD;
      every minute), right ventricle function and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, double blind, placebo-controlled clinical study involving 30 patients with&#xD;
      World Health Organization (WHO) Group 1 pulmonary arterial hypertension being treated with&#xD;
      ambrisentan randomized to receive placebo or spironolactone (50 mg/d) for 90 days using a&#xD;
      cross-over trial design.&#xD;
&#xD;
      Eligible participants will be randomized to receive placebo or spironolactone (50 mg/d) for&#xD;
      90 days (Phase I). At the completion of Phase I, participants will undergo repeat end-point&#xD;
      assessment followed by a 21-day drug washout period. Then, the 90 day crossover phase of the&#xD;
      trial will occur (Phase II), in which participants randomized to placebo in Phase I will be&#xD;
      treated with spironolactone (50 mg/d) in Phase II and vice versa. At the conclusion of Phase&#xD;
      II, end-point measures are reassessed.&#xD;
&#xD;
      Spironolactone is a diuretic used in treatment of PAH patients. Spironolactone is usually&#xD;
      added to medical treatment when doses of Lasix/Torsemide are increased and patients are at&#xD;
      risk for hypokalemia.&#xD;
&#xD;
      Study procedures being done for this research study are the standard procedures performed on&#xD;
      all PAH patients when they are in clinic for follow-up except for the Cardiopulmonary&#xD;
      Exercise Test (CPET) with Innocor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of Combination Ambrisentan + Spironolactone on Peak Volume of Oxygen Consumption (pVO2) and Cardiac Output</measure>
    <time_frame>Up to average of 20 min</time_frame>
    <description>Study the effect of combination ambrisentan (5-10 mg/d) + spironolactone (50 mg/d) on pVO2 and cardiac output. The pVO2 refers to a measure of general physical fitness measured during exercise.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Pulmonary Arterial Hypertension</condition>
  <arm_group>
    <arm_group_label>AMB + Spiro, Cardiopulmonary fitness</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ambrisentan 5 or 10 mg every day (QD) Spironolactone 50 mg QD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Cardiopulmonary fitness</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo mimics spironolactone 50 mg and will be taken QD</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ambrisentan plus Spironolactone</intervention_name>
    <description>Cardiopulmonary fitness</description>
    <arm_group_label>AMB + Spiro, Cardiopulmonary fitness</arm_group_label>
    <other_name>Letairis plus Aldactone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ambrisentan plus Placebo</intervention_name>
    <description>Placebo is a sugar pill manufactured to resemble spironolactone 50 mg Cardiopulmonary fitness</description>
    <arm_group_label>Placebo Cardiopulmonary fitness</arm_group_label>
    <other_name>Letairis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Voluntarily gives informed consent to participate in the study.&#xD;
&#xD;
          2. Right heart catheterization demonstrating conventional mean pulmonary artery pressure&#xD;
             (mPAP) &gt;25, pulmonary vascular resistance (PVR) &gt;3.0 Wood Units, pulmonary capillary&#xD;
             wedge pressure (PCWP) &lt;16 mmHg within two years of enrollment&#xD;
&#xD;
          3. Subject is 18 years of age or older at Screening.&#xD;
&#xD;
          4. Diagnosis of symptomatic idiopathic or heritable PAH, PAH associated with Connective&#xD;
             Tissue Disease (CTD), PAH associated with repaired/unrepaired congenital&#xD;
             systemic-to-pulmonary shunt, Portopulmonary hypertension or PAH associated with HIV&#xD;
             infection.&#xD;
&#xD;
          5. New York Heart Association Functional Class II or III&#xD;
&#xD;
          6. Stable therapy with ambrisentan 5 or 10 mg every day for &gt; 90 days.&#xD;
&#xD;
          7. Baseline 6-Minute Walk Distance 50-450m&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Substantial Primary Lung disease&#xD;
&#xD;
               -  forced expiratory volume at one second (FEV-1)/forced vital capacity (FVC) &lt;0.6&#xD;
                  and FEV-1 &lt;70% predicted&#xD;
&#xD;
               -  diffusing capacity of lung for carbon monoxide (DLCO) &lt;30% predicted&#xD;
&#xD;
               -  Pulmonary fibrosis&#xD;
&#xD;
          2. Left ventricular ejection fraction &lt; 50%&#xD;
&#xD;
          3. Pulmonary capillary wedge pressure &gt; 16 mm Hg&#xD;
&#xD;
          4. Aortic valve disease&#xD;
&#xD;
          5. Ischemic heart disease&#xD;
&#xD;
          6. Systemic hypotension (SBP &lt;90 mm Hg)&#xD;
&#xD;
          7. Co-existing treatment with other endothelin receptor antagonists or prostacyclin&#xD;
             analogues&#xD;
&#xD;
          8. New York Heart Association Functional Class IV&#xD;
&#xD;
          9. Chronic thromboembolic pulmonary hypertension&#xD;
&#xD;
         10. Known or suspected pulmonary veno-occlusive disease&#xD;
&#xD;
         11. Serum creatinine &gt;2.0 mg/dL in women, Serum creatinine &gt;2.5 mg/dL in men&#xD;
&#xD;
         12. Baseline serum potassium &gt;5.0 milliequivalent (mEq)/L&#xD;
&#xD;
         13. Participation in ongoing drug/intervention-based clinical trial&#xD;
&#xD;
         14. Pregnancy&#xD;
&#xD;
         15. Unable to provide consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bradley Maron, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham &amp; Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <results_first_submitted>August 28, 2019</results_first_submitted>
  <results_first_submitted_qc>November 13, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 15, 2019</results_first_posted>
  <last_update_submitted>November 13, 2019</last_update_submitted>
  <last_update_submitted_qc>November 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Bradley Maron, MD</investigator_full_name>
    <investigator_title>Instructor in Medicine</investigator_title>
  </responsible_party>
  <keyword>Pulmonary Arterial Hypertension (PAH)</keyword>
  <keyword>Ambrisentan</keyword>
  <keyword>Spironolactone</keyword>
  <keyword>Selective Endothelin A (ETA) inhibition</keyword>
  <keyword>Aldosterone antagonism</keyword>
  <keyword>Cardiac output (CO)</keyword>
  <keyword>Right ventricular (RV) function</keyword>
  <keyword>Heart failure</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Pro-inflammatory cytokine</keyword>
  <keyword>Interleukin-6 (IL-6)</keyword>
  <keyword>Troponin-I</keyword>
  <keyword>N-terminal pro-brain natriuretic peptide (NT-BNP)</keyword>
  <keyword>Collagen metabolism</keyword>
  <keyword>N-terminal procollagen type I</keyword>
  <keyword>Collagen III</keyword>
  <keyword>Echocardiography</keyword>
  <keyword>WHO Functional Class</keyword>
  <keyword>Cardiopulmonary Exercise Test with Innocor</keyword>
  <keyword>Peak oxygen consumption (pVO2)</keyword>
  <keyword>Liver function markers (AST/ALT)</keyword>
  <keyword>Renal function markers (creatinine and potassium)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Familial Primary Pulmonary Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ambrisentan</mesh_term>
    <mesh_term>Spironolactone</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 24, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT02253394/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>AMB + Spiro First, Then Placebo, Cardiopulmonary Fitness</title>
          <description>Ambrisentan 5 or 10 mg every day (QD) plus Spironolactone 50 mg QD FIRST, then placebo</description>
        </group>
        <group group_id="P2">
          <title>AMB + Placebo First, Then Spironolactone</title>
          <description>Ambrisentan 5 or 10 mg every day (QD) plus placebo first, then spironolactone 50 mg QD</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2">Ambrisentan 5 or 10 mg QD + placebo (90 d) first, then washout (21 d), then +Spiro 50 mg QD (90 d).</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AMB + Spiro, Cardiopulmonary Fitness</title>
          <description>Ambrisentan 5 or 10 mg every day (QD) Spironolactone 50 mg QD&#xD;
Ambrisentan plus Spironolactone: Cardiopulmonary fitness&#xD;
Cross over design</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61" lower_limit="58" upper_limit="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Study-Specific Measure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Effect of Combination Ambrisentan + Spironolactone on Peak Volume of Oxygen Consumption (pVO2) and Cardiac Output</title>
        <description>Study the effect of combination ambrisentan (5-10 mg/d) + spironolactone (50 mg/d) on pVO2 and cardiac output. The pVO2 refers to a measure of general physical fitness measured during exercise.</description>
        <time_frame>Up to average of 20 min</time_frame>
        <population>Data were not reported due to patient privacy considerations owing to low enrollment.</population>
        <group_list>
          <group group_id="O1">
            <title>AMB + Spiro, Cardiopulmonary Fitness</title>
            <description>Ambrisentan 5 or 10 mg every day (QD) Spironolactone 50 mg QD</description>
          </group>
          <group group_id="O2">
            <title>AMB + Placebo First</title>
            <description>Ambrisentan 5 or 10 mg QD + placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Combination Ambrisentan + Spironolactone on Peak Volume of Oxygen Consumption (pVO2) and Cardiac Output</title>
          <description>Study the effect of combination ambrisentan (5-10 mg/d) + spironolactone (50 mg/d) on pVO2 and cardiac output. The pVO2 refers to a measure of general physical fitness measured during exercise.</description>
          <population>Data were not reported due to patient privacy considerations owing to low enrollment.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>AMB + Spiro, Cardiopulmonary Fitness</title>
          <description>Ambrisentan 5 or 10 mg every day (QD) Spironolactone 50 mg QD&#xD;
Ambrisentan plus Spironolactone: Cardiopulmonary fitness</description>
        </group>
        <group group_id="E2">
          <title>Placebo Cardiopulmonary Fitness</title>
          <description>Placebo mimics spironolactone 50 mg and will be taken QD&#xD;
Ambrisentan plus Placebo: Placebo is a sugar pill manufactured to resemble spironolactone 50 mg Cardiopulmonary fitness</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Poor enrollment, study terminated early</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Bradley Maron</name_or_title>
      <organization>Brigham and Women's Hospital</organization>
      <phone>617-525-4857</phone>
      <email>bmaron@bwh.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02253394
org study id: CAPS_PAH
nct id: NCT02253394
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to find out if spironolactone added to ambrisentan for Pulmonary
      Arterial Hypertension (PAH) will increase exercise capacity. We also want to find out if
      spironolactone and ambrisentan effect the cardiac output (amount of blood the heart pumps
      every minute), right ventricle function and quality of life.
A prospective, double blind, placebo-controlled clinical study involving 30 patients with
      World Health Organization (WHO) Group 1 pulmonary arterial hypertension being treated with
      ambrisentan randomized to receive placebo or spironolactone (50 mg/d) for 90 days using a
      cross-over trial design.

      Eligible participants will be randomized to receive placebo or spironolactone (50 mg/d) for
      90 days (Phase I). At the completion of Phase I, participants will undergo repeat end-point
      assessment followed by a 21-day drug washout period. Then, the 90 day crossover phase of the
      trial will occur (Phase II), in which participants randomized to placebo in Phase I will be
      treated with spironolactone (50 mg/d) in Phase II and vice versa. At the conclusion of Phase
      II, end-point measures are reassessed.

      Spironolactone is a diuretic used in treatment of PAH patients. Spironolactone is usually
      added to medical treatment when doses of Lasix/Torsemide are increased and patients are at
      risk for hypokalemia.

      Study procedures being done for this research study are the standard procedures performed on
      all PAH patients when they are in clinic for follow-up except for the Cardiopulmonary
      Exercise Test (CPET) with Innocor.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Effect of Combination Ambrisentan + Spironolactone on Peak Volume of Oxygen Consumption (pVO2) and Cardiac Output
time frame: Up to average of 20 min
description: Study the effect of combination ambrisentan (5-10 mg/d) + spironolactone (50 mg/d) on pVO2 and cardiac output. The pVO2 refers to a measure of general physical fitness measured during exercise.
arm group label: AMB + Spiro, Cardiopulmonary fitness
arm group type: Active Comparator
description: Ambrisentan 5 or 10 mg every day (QD) Spironolactone 50 mg QD
arm group label: Placebo Cardiopulmonary fitness
arm group type: Placebo Comparator
description: Placebo mimics spironolactone 50 mg and will be taken QD
intervention type: Drug
intervention name: Ambrisentan plus Spironolactone
description: Cardiopulmonary fitness
arm group label: AMB + Spiro, Cardiopulmonary fitness
other name: Letairis plus Aldactone
intervention type: Drug
intervention name: Ambrisentan plus Placebo
description: Placebo is a sugar pill manufactured to resemble spironolactone 50 mg Cardiopulmonary fitness
arm group label: Placebo Cardiopulmonary fitness
other name: Letairis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bradley Maron, MD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Bradley Maron, MD
investigator title: Instructor in Medicine
mesh term: Pulmonary Arterial Hypertension
mesh term: Familial Primary Pulmonary Hypertension
mesh term: Hypertension
mesh term: Ambrisentan
mesh term: Spironolactone
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Poor enrollment, study terminated early
point of contact: 