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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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