Efficacy of Remodulin in Adults With Congenital Heart Disease (ACHD) and Pulmonary Hypertension
| Status: | Terminated |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2013 |
| End Date: | December 2015 |
The purpose of this study is to evaluate the efficacy of Remodulin in the treatment of adult
patients with congenital heart disease and pulmonary hypertension. Baseline and
post-treatment cardiopulmonary exercise tests will be performed.
patients with congenital heart disease and pulmonary hypertension. Baseline and
post-treatment cardiopulmonary exercise tests will be performed.
A prospective, open-label, non-randomized multi-center study is proposed to assess the
efficacy of Remodulin in adults with congenital heart disease and pulmonary hypertension.
Subjects will be enrolled at UCLA and Ohio State University (PI: Curt Daniels, MD). The
study will involve a six month trial of continuous subcutaneous Remodulin therapy, with
assessments conducted prior to initiation of therapy and at 1 and 6 months following
initiation of therapy. A separate initiation visit will be scheduled after the baseline
visit in order to provide subjects with comprehensive training in the use and care of the
Remodulin drug delivery system.
Baseline and post-treatment (6 month) assessments will include a history and physical
examination, cardiopulmonary exercise test, six minute walking distance, serum brain
natriuretic peptide (BNP), a Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
quality of life survey, and subjective assessment of functional capacity (New York Heart
Association (NYHA) scale). The interim (1 month) follow-up visit will include a thorough
review of adverse events associated with Remodulin therapy, functional class assessment, six
minute walk distance, and serum BNP.
Remodulin will be initiated at 1.25 ng/kg/min and increased by 2-6 ng/kg/min weekly to a
target dose of 40 ng/kg/min. If the initial infusion rate cannot be tolerated it will be
reduced to 0.625 ng/kg/min. Changes in drug dose will be at the discretion of the
investigators following review of interim events. If necessary, the dose may be decreased by
2 ng/kg/min every two days as tolerated.
efficacy of Remodulin in adults with congenital heart disease and pulmonary hypertension.
Subjects will be enrolled at UCLA and Ohio State University (PI: Curt Daniels, MD). The
study will involve a six month trial of continuous subcutaneous Remodulin therapy, with
assessments conducted prior to initiation of therapy and at 1 and 6 months following
initiation of therapy. A separate initiation visit will be scheduled after the baseline
visit in order to provide subjects with comprehensive training in the use and care of the
Remodulin drug delivery system.
Baseline and post-treatment (6 month) assessments will include a history and physical
examination, cardiopulmonary exercise test, six minute walking distance, serum brain
natriuretic peptide (BNP), a Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
quality of life survey, and subjective assessment of functional capacity (New York Heart
Association (NYHA) scale). The interim (1 month) follow-up visit will include a thorough
review of adverse events associated with Remodulin therapy, functional class assessment, six
minute walk distance, and serum BNP.
Remodulin will be initiated at 1.25 ng/kg/min and increased by 2-6 ng/kg/min weekly to a
target dose of 40 ng/kg/min. If the initial infusion rate cannot be tolerated it will be
reduced to 0.625 ng/kg/min. Changes in drug dose will be at the discretion of the
investigators following review of interim events. If necessary, the dose may be decreased by
2 ng/kg/min every two days as tolerated.
Inclusion Criteria:
- Age ≥ 18 years
- Congenital heart disease with Pulmonary Arterial (PA) hypertension (repaired or
unrepaired) defined as a mean resting directly measured Pulmonary Artery Pressure
(PAP) of ≥35 mm Hg and/or doppler echo estimated PA systolic pressure ≥ 60 mm Hg.
- Patients already on phosphodiesterase type 5 inhibitor (PDE-5), Endothelin Receptor
Antagonist (ERA), or inhaled prostacyclin are not excluded
Exclusion Criteria:
- Age < 18 years
- Current intravenous or subcutaneous prostacyclin therapy
- Resting systemic hypotension (Systolic blood pressure < 80 mm Hg)
- Women who are pregnant or may become pregnant (unwilling to utilize effective
contraception), as well as nursing mothers
- Inability to ambulate
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