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

• Status: Suspended
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Losartan

Criteria

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