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The Effects of Ambrisentan on Exercise Capacity in Fontan Patients

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ClinicalTrials.gov Identifier: NCT01971580
Recruitment Status : Completed
First Posted : October 29, 2013
Results First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Ari Cedars, Washington University School of Medicine

Brief Summary:

Hypothesis:

Patients with a Fontan type palliation are limited by preload, or the rate at which blood returns to the heart after passively traversing the pulmonary capillary bed. By decreasing pulmonary vascular resistance using an endothelin receptor antagonist, both ventricular filling pressures and volumes will increase with a simultaneous decrease in systemic impedance to flow and decrease in central venous pressures, leading to an improved capacity to increase cardiac output, and thereby an improvement in patient functional status.

Patients who are candidates for the study will be randomized to a double-blind single crossover study. Therapy with either ambrisentan or placebo will be continued for 12 weeks, with a 2 week washout period between treatment periods. Subjects will be subjected to a VO2 max test to evaluate exercise capacity at enrolment, and on the last day of each treatment period. As a component of the VO2 max testing the patient's VE, VCO2, VE/VCO2 slope, ventilatory anaerobic threshold (VAT), peak work, efficiency, and other physiologic parameters as typically obtained from cardiopulmonary testing will be assessed. In addition, each patient will be asked to complete an SF-36 quality of life questionnaire at enrollment, and on the last day of each study period.


Condition or disease Intervention/treatment Phase
Single Ventricle Fontan Palliation Drug: Ambrisentan Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Ambrisentan on Exercise Capacity in Fontan Patients
Study Start Date : August 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ambrisentan

Arm Intervention/treatment
Ambrisentan first, Placebo second
These patients will be randomized to have ambrisentan during the first study period, and placebo during the second study period.
Drug: Ambrisentan
Other Name: Letaris

Placebo first, Ambrisentan second
These patients will be randomized to have placebo during the first study period, and ambrisentan during the second study period.
Drug: Ambrisentan
Other Name: Letaris




Primary Outcome Measures :
  1. Change in VO2 Max [ Time Frame: Baseline compared to 12 weeks therapy with either ambrisentan or placebo ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 12 weeks ]
    Change in Rand 36-item Short Form (SF-36) physical function score (0-100). On the Rand SF-36 questionnaire, a score closer to 100 (higher) suggests lesser disability, while a score closer to 0 (lower) suggests more disability.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients over 18 years of age followed at the Center for Adults with Congenital Heart Disease at Washington University School of Medicine or at Saint Louis Childrens Hospital who have had a Fontan-type of palliation with single ventricular physiology.
  2. Patients must not within the last year have been treated with an endothelin receptor antagonist, phosphodiesterase 5 antagonist, or prostacyclin analogue.
  3. Female patients must not be pregnant, and during the study period must be using effective contraception (including barrier method with spermicide, intrauterine device, implanon, oral contraceptives) if fertile.
  4. In the physicians opinion patients must be able to complete a VO2 max test to achieve an RER of >1.0
  5. In the physicians opinion patients must be socially and intellectually able to adhere to the treatment regimen and follow-up
  6. Patients must be intellectually able to reliably complete an SF-36 questionnaire on quality of life.
  7. Patients must be clinically stable for at least 3 months prior to enrolment.
  8. Patients must not have had surgery within 6 months prior to enrolment, and have no planned surgery for the study period.
  9. Patients must provide informed consent.

    -

Exclusion Criteria:

  1. Patients under 18 years of age.
  2. Patients who are pregnant, nursing, or who in the physician's opinion are likely to become pregnant.
  3. Patients who are clinically unstable.
  4. Patients who have previously been treated with either an endothelin receptor antagonist and stopped due to adverse side effects.
  5. Patients with an AST or ALT of >3 x normal.
  6. Patients having any known contraindication to the initiation of ambrisentan.
  7. Patients with a calculated creatinine clearance of <60ml/min
  8. Patients with a serum hemoglobin concentration of <10mg/dl
  9. Patients with a poorly controlled cardiac arrhythmia
  10. Patients who are unable to provide independent informed consent.

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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): NCT01971580


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
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Responsible Party: Ari Cedars, Assistant Professor of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01971580    
Other Study ID Numbers: IN-US-300-D076
First Posted: October 29, 2013    Key Record Dates
Results First Posted: May 7, 2018
Last Update Posted: May 7, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Ambrisentan
Antihypertensive Agents