SuspendedPhase 1/2

Pilot Trial: the Safety and Feasibility of Losartan for Pulmonary Vein Stenosis

Stopped: Due to Health Canada losartan recall, a new formulation being added to the protocol/ temporary suspension

Canada40 participantsStarted 2016-05

Plain-language summary

This pilot study evaluates the safety and feasibility of losartan in pediatric patients with pulmonary vein stenosis. It is an open label single arm interventional study. The patient population involves pediatric patients with stenosis in 2 or more pulmonary veins. Patients will be given losartan for 1 year. Outcomes include measures of safety/adverse events and progression of pulmonary vein stenosis.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Stenosis involving 2 or more pulmonary veins * Consent of parent/legal guardian or child(when appropriate) Exclusion Criteria: * History of angioedema or allergic reaction to angiotensin converting enzyme inhibitors * corrected gestational age of less than 40 weeks * severe renal dysfunction * pregnancy

What they're measuring

Safety:Number of participants with adverse events

Timeframe: 12 months

Feasibility:Number of participants eligible and recruited

Timeframe: 12 months

Trial details

NCT IDNCT02769130

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05

View on ClinicalTrials.gov More Pulmonary Vein Stenosis trials