Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension

Stopped early · Not applicable · Has a placebo group

Conditions studied: Pre-Pulmonary Atrial Hypertension

In brief

This research study is looking at the use of the drug ambrisentan and if it can improve right ventricle function in people with systemic sclerosis-associated pre-pulmonary arterial hypertension. It is also looking at using right ventricle function changes as a marker of disease severity.

Key facts

Study ID

NCT02169752

Run by

National Jewish Health

People needed

7

Starts

2012-09-01

Expected to finish

2017-05-25

Last updated by the study team

2021-01-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years, < 80 years
• Systemic sclerosis with any of the following features:
• Duration of Raynaud's phenomena >8 years
• Anticentromere antibody positivity
• isolated nucleolar-pattern ANA positivity
• Extensive telangiectasias
• DLCO < 60% in the absence of extensive ILD
• FVC%/DLCO% >1.6
• Unexplained dyspnea
• Right heart catheterization-proven pre PAH (mean PAP 20-25 mmHg and pulmonary capillary wedge pressure <15 mmHg)
• Systolic blood pressure >100 mmHg
• Reliable contraception for women of childbearing age
• Informed consent

You may not qualify if…

• < 18 years or > 80 years
• Left ventricular ejection fraction < 55%
• Systolic or diastolic left ventricular congestive heart failure
• Liver disease (abnormal AST/ALT, chronic hepatitis, or cirrhosis)
• Extensive ILD or FVC< 60%
• Pregnant
• Breast-feeding women
• Cyclosporine use

Where it is running

• National Jewish Health — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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