Efficacy of Remodulin in Adults With Congenital Heart Disease (ACHD) and Pulmonary Hypertension
Information source: University of California, Los Angeles
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congenital Heart Disease
Intervention: Remodulin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of California, Los Angeles Official(s) and/or principal investigator(s):
Jamil A Aboulhosn, MD, Principal Investigator, Affiliation: UCLA Health System
Overall contact:
Jamil A Aboulhosn, MD, Phone: 310-825-9080, Email: JAboulhosn@mednet.ucla.edu
Summary
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.
Clinical Details
Official title: Efficacy of Remodulin in Adults With Congenital Heart Disease (ACHD) and Pulmonary Hypertension
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Improved cardiopulmonary exercise test
Secondary outcome: Improved overall cardiopulmonary variables
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Jamil A Aboulhosn, MD, Phone: 310-825-9080, Email: JAboulhosn@mednet.ucla.edu
UCLA Medical Center, Los Angeles, California 90095, United States; Recruiting
Jamil A Aboulhosn, MD, Phone: 310-825-9080, Email: JAboulhosn@mednet.ucla.edu
Gwendolyn Derk, BS, Phone: 310-825-5950, Email: GDerk@mednet.ucla.edu
Jamil A Aboulhosn, MD, Principal Investigator
Reardon Leigh, MD, Sub-Investigator
Ohio State University/Nationwide Children's Hospital, Columbus, Ohio 43205, United States; Recruiting
Curt J Daniels, MD, Phone: 614-722-2530, Email: Curt.Daniels@osumc.edu
Curt J Daniels, MD, Principal Investigator
Additional Information
UCLA Adult Congenital Heart Disease Center Ohio State University
Starting date: November 2013
Last updated: December 3, 2014
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