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Effects of Bosentan on the prognosis in patients after Fontan surgery: a randomized, double-blind, controlled trial

Effects of Bosentan on the prognosis in patients after Fontan surgery: a randomized, double-blind, controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-14005601
Enrollment
Unknown
Registered
2014-12-03
Start date
2012-12-31
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Congenital heart disease

Interventions

None listed

Sponsors

Wuhan Asia Heart Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 60 Years

Inclusion criteria

Inclusion criteria: Fontan/Modified Fontan

Exclusion criteria

Exclusion criteria: Age younger than 6 years; Preoperative echocardiographic estimates/Angiography right pulmonary artery pressure on average (mPAP) larger than 15 mm Hg (1 mm Hg=0.133 kPa); Pre-existing sinus rhythm; Pre-existing merged abnormal venous return; Pre-existing pulmonary artery distortion; Pre-existing hypohepatia (transaminase more than 3(Reference limit value); Pre-existing renal insufficiency (Cr more than 150mmol/L); Use of any except for the following drug: digoxin, Furosemide, spironolactone, potassium chloride, three months before surgery; Other system disease except for the cardiopathy, and chromosome abnormality; Female: HCG positive or no contraception methods; Patient who cannot cooperate with the inspectors since the mental factors; Patient not survived for one week after operation.

Design outcomes

Primary

MeasureTime frame
Death rate;

Secondary

MeasureTime frame
Incidence of Pulmonary arteriovenous fistula (PAVF);Cardiac function NYHA;ALT;6MWT;

Countries

China

Contacts

Public ContactXiaoke Shang
14236338@qq.com+86 18827338233

Outcome results

None listed

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