Pilot Study of Perindopril in Childhood Cancer Survivors

NCT01948232 | Withdrawn Phase 2 DMC

• 1 other identifier: 1000035483
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the feasibility of conducting a medical intervention trial in childhood cancer survivors with early echocardiographic evidence of cardiac remodeling.

Conditions

Childhood Cancer Survivors

Outcome Measures

Primary Outcomes (1)

• Proportion of patients consenting to study

  The number of eligible patients approached to join the study, the proportion consenting to the study, the proportion refusing the study (with reasons for refusal) and the proportion remaining on study at 18-months.

  18-month

Secondary Outcomes (1)

• LV wall thinning

  18 months

Study Arms (1)

Perindopril

EXPERIMENTAL

Drug: Perindopril

Interventions

Perindopril DRUG

Angiotensin converting enzyme inhibitor

Also known as: Coversyl

Perindopril

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Enrolled in the Survivor Cohort of the PCS2 study at The Hospital for Sick Children at the time of enrollment.
• Aged \< 20 years at enrollment.
• Weight ≥ 25kg at enrollment
• LVPW Z-score ≤-2.0 at any of the 0, 12 or 24 month PCS2 echocardiography assessments, on two consecutive echocardiograms at least 3 but no more than 15 months apart.
• EF greater than 50% at enrollment
• Serum potassium (to be ˃5.0mMol/l) at Initiation

You may not qualify if:

• Known associated cardiac conditions for which angiotensin converting enzyme therapy is contraindicated (such as aortic stenosis, severe coarctation of the aorta, or hypertrophic cardiomyopathy with LV outflow tract obstruction)
• Active malignancy detected within last 2 years (i.e. must be at least 2 years in remission)
• Prior radiation therapy to a field that involved the heart
• Prior symptomatic heart failure, or prior reduction in EF below 50% detected on surveillance echocardiography.
• Use of any cardioactive medications including diuretics within the last 6 months
• Concurrent serious or life threatening disease or extracardiac organ compromise which would limit participation in the trial or potentially have secondary effects on cardiac function, as determined by the treating physician.
• Renal dysfunction precluding ACEi therapy, defined as serum creatinine greater than the 95th percentile for age or eGFR by the modified Schwartz formula of less than the 5th percentile prior to recruitment to the interventional trial (within 30 days of recruitment date)
• Hypertension requiring treatment.
• History of angioedema or ACEi hypersensitivity
• Patients with hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the Lapp lactase deficiency.
• Upper airway obstructive lesions
• Pregnancy
• Breast-feeding

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1E2, Canada

Location

MeSH Terms

Interventions

Perindopril

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, AfterCare Program; Staff Oncologist

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 23, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

CA (1)