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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

Page last updated: August 23, 2015

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