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

NCT ID: NCT02769130

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2021-05-31

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.

Conditions

Pulmonary Vein Stenosis; Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Losartan

Intervention Type: DRUG

Losartan is given for 12 months

Interventions

Losartan

Losartan is given for 12 months

Intervention Type: DRUG

Other Intervention Names

Cozaar

Eligibility 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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Christopher Caldarone

Surgeon in Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher A Caldarone, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000051475

Identifier Type: -

Identifier Source: org_study_id