Efficacy of Remodulin in Adults With Congenital Heart Disease (ACHD) and Pulmonary Hypertension

Withdrawn before enrolling · Not applicable

Conditions studied: Congenital Heart Disease

In brief

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.

Key facts

Study ID

NCT01980979

Run by

University of California, Los Angeles

People needed

0

Starts

2013-11-01

Expected to finish

2015-12-01

Last updated by the study team

2017-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA Medical Center — Los Angeles, California, United States
• Ohio State University/Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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