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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pilot Trial: the Safety and Feasibility of Losartan Therapy for Treatment of Pulmonary Vein Stenosis in Pediatric Patients

Brief 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.


Detailed Summary:

This pilot study evaluates the safety and feasibility of losartan in pediatric patients with pulmonary vein stenosis.

Large animal studies have demonstrated that losartan can ameliorate the progression of pulmonary vein stenosis in a surgical model of pulmonary vein stenosis.

There is no safety data for losartan in children < 6months of age or in children with pulmonary vein stenosis. Therefore, this study will test the safety and feasibility of losartan in children in an open label single arm interventional study.

Patient inclusion criteria includes stenosis involving 2 or more pulmonary veins. Patients who are consented into the trial with be on losartan therapy for one year. They will undergo study visits every 3 months. Patients will be screened for adverse events through biochemical tests, routine clinical tests and questionnaires.

An exploratory efficacy analysis will compare progression of pulmonary vein stenosis in children enrolled in losartan to a contemporary cohort of children with pulmonary vein stenosis, who did not receive losartan.


Sponsor: The Hospital for Sick Children

Current Primary Outcome:

  • Safety:Number of participants with adverse events [ Time Frame: 12 months ]
    adverse events include hypotension, hyperkalemia, renal dysfunction
  • Feasibility:Number of participants eligible and recruited [ Time Frame: 12 months ]
    includes patient recruitment and compliance with protocol


Original Primary Outcome: Same as current

Current Secondary Outcome: Progression of pulmonary vein stenosis: survival [ Time Frame: 12 months ]

Progression of pulmonary vein stenosis measures include survival, morbidity and evidence of progression on clinical tests


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: May 9, 2016
Date Started: May 2016
Date Completion: May 2019
Last Updated: May 9, 2016
Last Verified: May 2016