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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01548950 |
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Date of registration:
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05/03/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension
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Scientific title:
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Combined Clinical and Surgical Approaches to Congenital Heart Disease Associated With Pulmonary Arterial Hypertension (PAH-CHD) |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01548950 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Antonio Augusto Lopes, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto do Coração (InCor) - HCFMUSP - São Paulo - Brazil |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Potentially operable patients with congenital cardiac septal defects (bi-ventricular
physiology) and PAH, must have at least three of the following severity criteria: age
> 18 months; absence of congestive heart failure (pulmonary congestion); Down
syndrome; bidirectional shunting across the septal defect; periods of systemic
(peripheral) oxygen saturation < 90%.
Exclusion Criteria:
- Patients with complex cardiac anomalies for whom there are no possibilities of
complete repair. Patients with uni-ventricular physiology.
Age minimum:
2 Months
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Congenital Heart Disease
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Intervention(s)
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Drug: Sildenafil singly or in association with Bosentan
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Primary Outcome(s)
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Immediate postoperative right cardiac failure and mortality, and prevalence of residual PAH six months after surgery.
[Time Frame: Six months following surgery]
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Secondary Outcome(s)
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Pulmonary vascular resistance six months after surgical repair of congenital cardiac shunts with PAH
[Time Frame: Six months following surgery]
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Secondary ID(s)
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CAPPesq 0502/11
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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