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Ambrisentan in Single Ventricle

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ClinicalTrials.gov Identifier: NCT02080637
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Kevin Hill, Duke University

Brief Summary:

Purpose: To evaluate the pharmacokinetics, bioavailability and hemodynamic efficacy of ambrisentan after Fontan surgical palliation of single ventricle heart defects.

Study activities and population group: Children undergoing Fontan surgical palliation for single ventricle defects will be eligible for the study. Up to 20 subjects will be enrolled (16 ambrisentan, 4 placebo) and will receive 3 days (3 doses) of ambrisentan starting on post-operative day #1 upon returning from the operating room. Ambrisentan plasma levels will be obtained at specified time points during treatment. Post-operative monitoring lines will be used to measure effects of ambrisentan on hemodynamics and pulmonary / systemic endothelial function.


Condition or disease Intervention/treatment Phase
Hypoplastic Left Heart Syndrome Hypoplastic Right-sided Heart Complex Drug: Ambrisentan Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Safety, Pharmacokinetics (PK) and Hemodynamic Effects of Ambrisentan in Single Ventricle Pediatric Patients
Study Start Date : July 2015
Actual Primary Completion Date : July 20, 2017
Actual Study Completion Date : August 20, 2017


Arm Intervention/treatment
Active Comparator: Ambrisentan
Oral ambrisentan 2.5 - 5 mg, single dose, once daily
Drug: Ambrisentan
Once daily oral dosing
Other Name: Leitaris

Placebo Comparator: Placebo
Oral placebo 2.5 - 5 mg, single dose, once daily
Other: Placebo



Primary Outcome Measures :
  1. Area Under the Curve for Ambrisentan Plasma Concentration [ Time Frame: 0-1,1-6,18-30 and 40-60 hours ]
    Plasma samples collected at 0-1,1-6,18-30 and 40-60 hours after administration of the first ambrisentan dose.

  2. Change in Pulmonary Vascular Resistance Index [ Time Frame: baseline to 2 hours post ambrisentan administration ]
    Hemodynamic data, including Fontan pressures, common atrial pressures and saturations, will be collected at the specified timepoints. Pressures and saturations will be measured from existing monitoring lines. Standard Fick calculations will be used to calculate pulmonary vascular resistance (calculated as trans-pulmonary gradient [Fontan pressure - atrial pressure] / pulmonary blood flow [Qp]) and reported in Wood Units x m^2.


Secondary Outcome Measures :
  1. Amount of Chest Tube Drainage Post Fontan Operation [ Time Frame: 0-96 hours post Fontan ]
    Total chest tube drainage in mL in first 96hrs after Fontan

  2. Duration of Chest Tube Drainage Post Fontan Operation [ Time Frame: measured for the duration of the post-operative hospitalization or for 30 days, whichever is shorter ]
    Chest tube duration will be calculated as the number of days from placement to removal.



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Ages Eligible for Study:   24 Months to 120 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 24 months; ≤120 months.
  2. History of congenital heart disease with severe hypoplasia of a right or left ventricle.
  3. Undergoing Fontan surgery as part of standard clinical care.
  4. Availability and willingness of the parent/legally authorized representative to provide written informed consent and, as appropriate, assent from the child.

Exclusion Criteria:

  1. History of serious adverse event related to ambrisentan administration.
  2. History of ambrisentan exposure within 48 hours of the study.
  3. Presence of pulmonary venous obstruction.
  4. Treatment with cyclosporin.
  5. Any of the following - as determined by the attending physician

    • Significant hemodynamic instability
    • Sepsis.
    • Need for ECMO support.
  6. Renal failure defined as serum creatinine > 2 times higher than the upper limit of normal.
  7. Liver dysfunction defined as alanine aminotransferase or aspartate aminotransferase > 3 times higher than the upper limit of normal.
  8. Thrombocytopenia defined as a platelet count < 50 000 cells/µL.
  9. Leukopenia defined as white blood cells < 2500 cells/µL.
  10. Anemia defined as hemoglobin < 8mg/dL.
  11. Atrial hypertension (mean LA pressure > 12mm Hg).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02080637


Locations
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United States, North Carolina
Duke Universtiy Hospital
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Kevin Hill
Investigators
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Principal Investigator: Kevin Hill, MD Duke University
  Study Documents (Full-Text)

Documents provided by Kevin Hill, Duke University:
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Responsible Party: Kevin Hill, Assist Professor, Duke University
ClinicalTrials.gov Identifier: NCT02080637    
Other Study ID Numbers: Pro00050118
First Posted: March 6, 2014    Key Record Dates
Results First Posted: September 12, 2019
Last Update Posted: September 12, 2019
Last Verified: August 2019
Keywords provided by Kevin Hill, Duke University:
Single ventricle
Additional relevant MeSH terms:
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Hypoplastic Left Heart Syndrome
Dextrocardia
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Situs Inversus
Ambrisentan
Antihypertensive Agents