Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01723371|
Recruitment Status : Withdrawn (Due to lack of enrollment.)
First Posted : November 7, 2012
Last Update Posted : December 31, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: Carvedilol||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||September 2015|
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
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
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Mark Friedberg, MD||The Hospital for Sick Children|