Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children
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ClinicalTrials.gov Identifier: NCT01723371 |
Recruitment Status :
Withdrawn
(Due to lack of enrollment.)
First Posted : November 7, 2012
Last Update Posted : December 31, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Arterial Hypertension | Drug: Carvedilol | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | September 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Carvedilol |
Drug: Carvedilol
Carvedilol will be administered orally. The initial dose of carvedilol will be 0.05mg/kg/day divided into 2 doses. After two weeks, at subsequent weekly study visits, the dose of carvedilol will be increased incrementally to 0.1mg/kg in Week 2, 0.2mg/kg in Week 3, 0.4mg/kg in Week 4, 0.6mg/kg in Week 5, and 0.8mg/kg in Week 6, when the target dose of 0.8mg/kg/day (if weight is less than 62.5kg) or 50mg/day (if weight is greater than 62.5kg) is achieved. This dosage, assuming no adverse effects, will be maintained between Weeks 6 and 30 of the study. After the maintenance period from Week 6 to 30, patients will be weaned over 5 to 7 days or continued on a non-study drug supply. |
- Incidence of Adverse Events [ Time Frame: Throughout study (Baseline to week 31) ]-Incidence of major adverse effects defined as bradycardia, hypotension, and syncope, worsening of symptoms, disease state and death
- Improvement in the six minute walk test (6MWT) and cardiopulmonary exercise testing (CPX) [ Time Frame: Change over 6 months ]This will be measured by the difference in walking distance in the 6MWT and peak oxygen consumption in the CPX, between the baseline condition before the study and after 6 months with maintenance dose of carvedilol.
- Improvement in echocardiogram and magnetic resonance imaging (MRI) parameters [ Time Frame: Change over 6 months ]The echocardiogram will be a subjective assessment of the right valve (RV) fractional area of change through TAPSE. The MRI will measure the RV ejection fraction. Both indicators will measure the different between the baseline condition before the study and after 6 months with maintenance dose of carvedilol.
- Feasibility of carvedilol [ Time Frame: Baseline, Week 0, 2, 3, 4, 5, 6, 10, 18, 22, 30, 31 ]
- Proportion of patients achieving target maintenance dose of carvedilol
- Proportion of patients requiring dose adjustment due to bradycardia and/or hypertension
- Proportion of patients stopping treatment with carvedilol due to serious adverse events

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Ages Eligible for Study: | 8 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 β-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 β-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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723371
Canada, Ontario | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada, M5G 1X8 |
Principal Investigator: | Mark Friedberg, MD | The Hospital for Sick Children |
Responsible Party: | Mark Friedberg, Staff Cardiologist, The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT01723371 |
Other Study ID Numbers: |
1000031903 |
First Posted: | November 7, 2012 Key Record Dates |
Last Update Posted: | December 31, 2015 |
Last Verified: | December 2015 |
Pulmonary Arterial Hypertension (PAH Pediatrics Right Heart Failure (RHF) Carvedilol Beta-blockers |
Pulmonary Arterial Hypertension Familial Primary Pulmonary Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Carvedilol Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antihypertensive Agents Antioxidants Protective Agents Calcium Channel Blockers Membrane Transport Modulators Calcium-Regulating Hormones and Agents Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |