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

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02769130
• Other study ID #: 1000051475
• Status: Suspended
• Phase: Phase 1/Phase 2
• Start date: May 2016
• Est. completion date: May 2021

Study information

• Verified date: July 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Children
• Constriction, Pathologic
• Pulmonary Vein Stenosis

Intervention

Drug:
• Losartan
Losartan is given for 12 months

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety:Number of participants with adverse events	adverse events include hypotension, hyperkalemia, renal dysfunction	12 months
Primary	Feasibility:Number of participants eligible and recruited	includes patient recruitment and compliance with protocol	12 months
Secondary	Progression of pulmonary vein stenosis: survival	Progression of pulmonary vein stenosis measures include survival, morbidity and evidence of progression on clinical tests	12 months