Trial · NCT01548950
Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension
NCT01548950, Not applicable, Completed, University of Sao Paulo General Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension. Trials, record NCT01548950. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01548950
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension
- NCT number
- NCT01548950
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 50 participants, actual
- Lead sponsor
- University of Sao Paulo General Hospital
- Conditions
- Congenital Heart Disease, Pulmonary Arterial Hypertension
- Interventions
- Sildenafil singly or in association with Bosentan
- First posted
- 2012-03-08
- Last updated
- 2020-03-30
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Immediate postoperative right cardiac failure and mortality, and prevalence of residual PAH six months after surgery. | Six months following surgery | Drug treatment must reduce the prevalence of immediate postoperative right cardiac failure / death to \<10%, and the prevalence of residual PAH six months after cardiac surgery to \<10%. Residual PAH is defined as an elevation of mean pulmonary artery pressure above 25 mmHg, and elevation of pulmonary vascular resistance above 3.0 Wood units x squared meters (body surface area). |
| Secondary | Pulmonary vascular resistance six months after surgical repair of congenital cardiac shunts with PAH | Six months following surgery | Drug treatment before surgery and maintained for six months following repair of congenital cardiac shunts must promote a statistically significant reduction in pulmonary vascular resistance (at six months) compared with baseline (preoperative) level. |
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/NCT01548950
GET https://conductscience.org/api/trials/v1/NCT01548950/registered