Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2016
• Main ID: NCT01723371
• Date of registration: 31/10/2012
• Prospective Registration: No
• Primary sponsor: The Hospital for Sick Children
• Public title: Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children
• Scientific title: Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children
• Date of first enrolment: September 2012
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01723371
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Canada

Contacts

• Name: Mark Friedberg, MD
• Affiliation: The Hospital for Sick Children

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must be = 8 and = 17.5 years of age at the time of study enrollment.

- Patients must have a mean pulmonary artery pressure of greater than 25mmHg at rest in
a setting of normal pulmonary arterial wedge pressure of 15mmHg or less with a PVR
index greater than 3 Woods units•m2 at last hemodynamic study.

- Patients must be diagnosed with any of the following:Idiopathic PAH (IPAH), PAH
associated with repaired congenital heart disease, PAH associated with minor
congenital heart disease (small interventricular communication, small interarterial
communication, small ductus arteriosis)

- Patients must be clinically stable (i.e. no treatment changes) for the last 3 months

- Patients must have no or minimal evidence of fluid overload or volume depletion
judged by clinical evaluation (with or without diuretic treatment)

- Written informed consent

Exclusion Criteria:

- Patients who are unable to perform a six minute walk test (6MWT)

- Patients with a known history of pulmonary hypertension secondary to venoocclusive
disease and/or capillary hemangiomatosis; pulmonary hypertensions owing to left heart
disease

- Patients who have previously received treatment with an intravenous positive
inotropic agent in the last 3 months

- Patients who are currently receiving ß-blockers

- Patients with a known history of reactive airways disease (bronchial asthma or relate
bronchospastic conditions)

- Patients with chronic obstructive pulmonary disease (COPD)

- Patients with a known history of adverse reaction to ß-blockers

- Patients with a heart block on ECG or resting heart rate < 60 bpm

- Patients with systemic hypotension (below 5th percentile for age) are not eligible as
follows: 1-10 years old: systolic blood pressure defined as < [70 + (2 x age in
years)] mmHg; Older than 10 years: systolic blood pressure < 90 mmHg

- Patients with coagulopathy (INR < 1.5 or platelet count <50,000/mm3)

- Patients with a known history of severe hepatic impairment (defined by the presence
of ascites, esophageal varices, jaundice or spider angiomata)

- Patients with severe renal insufficiency (defined as creatinine clearance < 30
mL/min/m2)

- Patients with a known malignancy or other co-morbidity expected to limit survival or
to limit the ability to complete the study

- Patients with trisomy 21

- Patients with a known history of sick sinus syndrome

- Patients with a known history of moderate or severe primary obstructive valvular
heart disease

- Patients with a known history of diabetes

- Female patients who are pregnant of breast-feeding



Age minimum: 8 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Carvedilol

Primary Outcome(s)

Incidence of Adverse Events [Time Frame: Throughout study (Baseline to week 31)]

Secondary Outcome(s)

Improvement in the six minute walk test (6MWT) and cardiopulmonary exercise testing (CPX) [Time Frame: Change over 6 months]

Feasibility of carvedilol [Time Frame: Baseline, Week 0, 2, 3, 4, 5, 6, 10, 18, 22, 30, 31]

Improvement in echocardiogram and magnetic resonance imaging (MRI) parameters [Time Frame: Change over 6 months]

Secondary ID(s)

1000031903

Source(s) of Monetary Support

Please refer to primary and secondary sponsors