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

NCT02769130 | Suspended Phase 1 DMC

• 1 other identifier: 1000051475
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Vein Stenosis; Children

Outcome Measures

Primary Outcomes (2)

• Safety:Number of participants with adverse events

  adverse events include hypotension, hyperkalemia, renal dysfunction

  12 months

• Feasibility:Number of participants eligible and recruited

  includes patient recruitment and compliance with protocol

  12 months

Secondary Outcomes (1)

• Progression of pulmonary vein stenosis: survival

  12 months

Study Arms (1)

Losartan

EXPERIMENTAL

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.

Drug: Losartan

Interventions

Losartan DRUG

Losartan is given for 12 months

Also known as: Cozaar

Losartan

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Stenosis involving 2 or more pulmonary veins
• Consent of parent/legal guardian or child(when appropriate)

You may not qualify if:

• History of angioedema or allergic reaction to angiotensin converting enzyme inhibitors
• corrected gestational age of less than 40 weeks
• severe renal dysfunction
• pregnancy

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, m5g 0a4, Canada

Location

MeSH Terms

Conditions

Stenosis, Pulmonary Vein

Interventions

Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Christopher A Caldarone, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon in Chief

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 11, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)