Trial · NCT01827059
Bosentan In Exercise Induced Pulmonary Arterial Hypertension in CongenitaL Heart diseasE
NCT01827059, Phase 2, Unknown, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bosentan In Exercise Induced Pulmonary Arterial Hypertension in CongenitaL Heart diseasE. Trials, record NCT01827059. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01827059
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bosentan In Exercise Induced Pulmonary Arterial Hypertension in CongenitaL Heart diseasE
- NCT number
- NCT01827059
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Conditions
- Pulmonary Arterial Hypertension, Congenital Heart Disease
- Interventions
- Bosentan, Placebo
- First posted
- 2013-04-09
- Last updated
- 2017-08-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in mean pulmonary arterial pressure (mPAP) at peak exercise | 26 weeks | * measured by means of transthoracic echocardiography at 3 and 6 months followup: mPAP = 0.6 x systolic PAP. * peak exercise is defined as 80% of maximum calculated heart rate: peak exercise=0.8\*(220-age) |
| Secondary | Cardiopulmonary exercise capacity | 26 weeks | o i.e. peak oxygen consumption, VE/VCO2 ratio, O2 pulse |
| Secondary | Pulmonary hemodynamics | 26 weeks | o i.e. systolic pulmonary arterial pressure, pulmonary vascular resistance, pressure-flow relationships during and at peak exercise |
| Secondary | Right ventricular function | 26 weeks | o i.e. TAPSE, TEI index, TDI-S, right ventricular dimensions |
| Secondary | Laboratory parameters | 26 weeks | o i.e. NT-pro BNP, troponin T |
| Secondary | NYHA functional class | 26 weeks | |
| Secondary | Quality of life | 26 weeks | o assessed by TAAQOL-CHD, SF-36 and Minnesota CHD-HF questionnaire |
| Secondary | Demographics | 26 weeks | * age, gender, marital status, work, income. * assessed by demographic questionnaire |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01827059
GET https://conductscience.org/api/trials/v1/NCT01827059/registered