Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension
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|ClinicalTrials.gov Identifier: NCT01548950|
Recruitment Status : Unknown
Verified June 2015 by University of Sao Paulo General Hospital.
Recruitment status was: Recruiting
First Posted : March 8, 2012
Last Update Posted : June 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease Pulmonary Arterial Hypertension||Drug: Sildenafil singly or in association with Bosentan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined Clinical and Surgical Approaches to Congenital Heart Disease Associated With Pulmonary Arterial Hypertension (PAH-CHD)|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||December 2016|
U.S. FDA Resources
Preoperatively, sildenafil until development of pulmonary congestion (1-4 weeks). On treatment pulmonary congestion (dyspnea and need for increasing diuretics) occurs when there is a substantial decrease in pulmonary vascular resistance, which may be confirmed noninvasively by Doppler-echocardiography. At that moment, patient will be assigned to surgery. If pulmonary congestion is not observed, bosentan will be added on top of sildenafil, and the patient will be kept on treatment for 10-12 months. In this case, a new cardiac catheterization will be performed before surgery. In both cases (short-term and medium-term treatment) patients will be kept on treatment for six months following surgery, and then re-catheterized.
Drug: Sildenafil singly or in association with Bosentan
Sildenafil, 1-4 mg/Kg/day (6-hour intervals) preoperatively, until development of pulmonary congestion (generally 1-4 weeks) or preoperatively, for 10-12 months, in association with bosentan (15.6-62.5 mg b.i.d.) if pulmonary congestion does not develop. Surgery will be performed at 1-4 weeks (short-term treatment) or at 10-12 months (medium-term treatment) if operability criteria are met (catheterization). In both cases (short and medium-term treatments), the drug or drugs will be kept for 6 months postoperatively, when final catheterization will be performed for efficacy testing.
- Immediate postoperative right cardiac failure and mortality, and prevalence of residual PAH six months after surgery. [ Time Frame: 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).
- Pulmonary vascular resistance six months after surgical repair of congenital cardiac shunts with PAH [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548950
|Contact: Antonio Augusto B. Lopes, M.D.||55-11-2661-5000 ext email@example.com|
|Contact: Roseli Polo, Assistant||55-11-2661-5000 ext firstname.lastname@example.org|
|Instituto do Coração (InCor) HCFMUSP||Recruiting|
|São Paulo, Brazil, 05403-900|
|Contact: Antonio Augusto Lopes, M.D. 55-11-2661-5000 ext 5350 email@example.com|
|Contact: Roseli Polo, Assistant 55-11-2661-5000 ext 5350 firstname.lastname@example.org|
|Sub-Investigator: Ana Maria Thomaz, M.D.|
|Sub-Investigator: Nair Y. Maeda, PhD|
|Sub-Investigator: Vera D. Aiello, M.D.|
|Sub-Investigator: Luiz J. Kajita, M.D.|
|Sub-Investigator: Filomena Regina BG Galas, M.D.|
|Sub-Investigator: Leína Zorzanelli, M.D.|
|Sub-Investigator: Arlindo A. Riso, M.D.|
|Sub-Investigator: Marcelo B. Jatene, M.D.|
|Sub-Investigator: Sérgio P. Bydlowski, M.D.|
|Principal Investigator:||Antonio Augusto Lopes, M.D.||Instituto do Coração (InCor) - HCFMUSP - São Paulo - Brazil|