Trial · NCT02080637
Ambrisentan in Single Ventricle
NCT02080637, Phase 2, Completed, Kevin Hill; results first posted 2019-09-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ambrisentan in Single Ventricle. Trials, record NCT02080637. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02080637
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ambrisentan in Single Ventricle
- NCT number
- NCT02080637
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Kevin Hill
- Conditions
- Hypoplastic Left Heart Syndrome, Hypoplastic Right-sided Heart Complex
- Interventions
- Ambrisentan, Placebo
- First posted
- 2014-03-06
- Last updated
- 2019-09-12
- Results first posted
- 2019-09-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve for Ambrisentan Plasma Concentration | 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. |
| Primary | Change in Pulmonary Vascular Resistance Index | 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 | Amount of Chest Tube Drainage Post Fontan Operation | 0-96 hours post Fontan | Total chest tube drainage in mL in first 96hrs after Fontan |
| Secondary | Duration of Chest Tube Drainage Post Fontan Operation | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve for Ambrisentan Plasma Concentration | 0-1,1-6,18-30 and 40-60 hours | Five participants did not have all samples collected. Outcome measure not applicable to the Placebo group. | ng*hr/mL | GEOMETRIC_MEAN |
| PRIMARY | Change in Pulmonary Vascular Resistance Index | baseline to 2 hours post ambrisentan administration | One participant in the Ambrisentan group had central line removed early; Fontan pressures could not be measured. | WU*m^2 | MEAN |
| SECONDARY | Amount of Chest Tube Drainage Post Fontan Operation | 0-96 hours post Fontan | milliliters | MEAN | |
| SECONDARY | Duration of Chest Tube Drainage Post Fontan Operation | measured for the duration of the post-operative hospitalization or for 30 days, whichever is shorter | days | MEAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Curve for Ambrisentan Plasma Concentration | Ambrisentan | 7871.46 | Geometric Coefficient of Variation 36.96 | ng*hr/mL | |
| Change in Pulmonary Vascular Resistance Index | Ambrisentan | -0.5 | Standard Deviation 0.5 | WU*m^2 | |
| Change in Pulmonary Vascular Resistance Index | Placebo | -0.2 | Standard Deviation 0.5 | WU*m^2 | |
| Amount of Chest Tube Drainage Post Fontan Operation | Ambrisentan | 1325 | Standard Deviation 531 | milliliters | |
| Amount of Chest Tube Drainage Post Fontan Operation | Placebo | 1356 | Standard Deviation 622 | milliliters | |
| Duration of Chest Tube Drainage Post Fontan Operation | Ambrisentan | 6.54 | Standard Deviation 3.9 | days | |
| Duration of Chest Tube Drainage Post Fontan Operation | Placebo | 5.33 | Standard Deviation 1.5 | days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ambrisentan | 13 | |
| Overall Study | STARTED | Placebo | 3 | |
| Overall Study | COMPLETED | Ambrisentan | 13 | |
| Overall Study | COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Ambrisentan | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Electrolyte abnormalities | Metabolism and nutrition disorders | Ambrisentan | 8 | 13 | |
| other | Electrolyte abnormalities | Metabolism and nutrition disorders | Placebo | 2 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Ambrisentan | 2 | 13 | |
| other | Anemia | Blood and lymphatic system disorders | Placebo | 0 | 3 | |
| other | Prolonged pleural effusion or chylothorax | Respiratory, thoracic and mediastinal disorders | Ambrisentan | 3 | 13 | |
| other | Prolonged pleural effusion or chylothorax | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 3 | |
| other | Hypertension requiring treatment | Cardiac disorders | Ambrisentan | 1 | 13 | |
| other | Hypertension requiring treatment | Cardiac disorders | Placebo | 0 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ambrisentan | 0 | 13 |
| Total, all-cause mortality | Placebo | 0 | 3 |
| Total, other adverse events | Ambrisentan | 8 | 13 |
| Total, other adverse events | Placebo | 2 | 3 |
| Total, serious adverse events | Ambrisentan | 0 | 13 |
| Total, serious adverse events | Placebo | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ambrisentan vs Placebo: deaths from any cause | Trial comparisons |
| Ambrisentan vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02080637
GET https://conductscience.org/api/trials/v1/NCT02080637/registered