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NCT01971580 · ClinicalTrials.gov registry record · Phase 4
The Effects of Ambrisentan on Exercise Capacity in Fontan Patients
A Phase 4 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT01971580 is a Phase 4 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 28 participants.
The verdict
NCT01971580, a Phase 4 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study 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.
Interventions
- DRUG Ambrisentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01971580
The ClinicalTrials.gov registry entry for NCT01971580 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ambrisentan is the first listed.
NCT01971580 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01971580 about?
NCT01971580 is a clinical study titled "The Effects of Ambrisentan on Exercise Capacity in Fontan Patients". 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 ...
What is the current status of trial NCT01971580?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2012-08. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01971580?
The interventions under investigation include: Ambrisentan (DRUG).
Who is sponsoring clinical trial NCT01971580?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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