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

Phase 1

Suspended

• Conditions: Children; Pulmonary Vein Stenosis
• Interventions: Drug: Losartan

• Registration Number: NCT02769130
• Lead Sponsor: The Hospital for Sick Children

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 Description

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-11
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-28
• Last Update Posted: 2019-07-30
• Primary Completion: 2021-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Losartan	Losartan	Losartan will be given to children with stenosis in greater or equal to 2 pulmonary veins. Maintenance daily dosing is 1mg/kg/day using suspension or tablet formulation of losartan. Losartan will be given for 1 year.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Progression of pulmonary vein stenosis: survival	12 months	Progression of pulmonary vein stenosis measures include survival, morbidity and evidence of progression on clinical tests

Trial Locations

Locations (1)

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada