Examination of the effectiveness of sildenafil in preventing lung vessel constriction after heart surgery in children

Double blinded randomised trial for the evaluation of the effectiveness of prophylactic use of sildenafil for the prevention of pulmonary hypertensive crisis after congenital heart surgery - Sildenafilstudy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005440-98-AT

Enrollment

Registered

2012-03-07

Start date

2012-04-12

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventriculs septal defect, atrioventricular canal with pulmonary hypertension MedDRA version: 14.1 Level: HLT Classification code 10010401 Term: Congenital cardiovascular anomaly therapeutic procedures System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Revatio 20 mg Product Name: Revatio 20 mg Pharmaceutical Form: Coated tablet Other descriptive name: Sildenafil Concentration unit: mg milligram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Ventricular septal defect, AV-Canal with pulmonary hypertension informed parental consent age 0-2 years Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: additional structural abnormalities affecting pulmonary resistance ventilation preoperatively residual VSD high dosage of catecholamines, hemodynamic instability extracorporeal technics abnormalities of oesophagus with contraindication for transoesophegeal Doppler

Design outcomes

Primary

Measure	Time frame
Main Objective: Frequency of pulmonary hypertensive crises;Secondary Objective: mean pulmonary artery pressure cardiac output by transoesophageal Doppler fluid balance length of ventilation length of ICU stay ;Primary end point(s): number of pulmonary hypertensive crises;Timepoint(s) of evaluation of this end point: 0,6,12,24,36,48 hours after admission	—

Secondary

Measure	Time frame
Secondary end point(s): mean pulmonary pressure fluid balance cardiac output duration of ventilation duration of ICU stay German;Timepoint(s) of evaluation of this end point: 0,6,12,24,36,48 hours after admission	—

Countries

Austria

Contacts

Public ContactAnaesthesie

AKH Linz

anna.hofer@akh-linz.at004373278062158

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026