Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension
| Status: | Terminated |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Dermatology, Dermatology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 8/26/2018 |
| Start Date: | September 2012 |
| End Date: | May 25, 2017 |
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.
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.
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.
Pre-pulmonary arterial hypertension is a borderline elevation in blood pressure in the lungs.
Pre-pulmonary arterial hypertension is not currently treated with the drug therapies that are
used for pulmonary arterial hypertension. It represents a group of patients that are at risk
for developing pulmonary arterial hypertension.
The administration of ambrisentan is the experimental part of this study. Ambrisentan has not
been approved by the FDA for use of improving right ventricle function in people with
pre-pulmonary arterial hypertension. You will still receive your normal clinical care.
The purpose of this study is to learn more about ambrisentan and its role in treating
systemic sclerosis-associated pre-pulmonary arterial hypertension. Ambrisentan is already
approved for use in people with systemic sclerosis-associated pulmonary arterial
hypertension, but this study wants to research its role in people with pre-pulmonary arterial
hypertension.
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.
Pre-pulmonary arterial hypertension is a borderline elevation in blood pressure in the lungs.
Pre-pulmonary arterial hypertension is not currently treated with the drug therapies that are
used for pulmonary arterial hypertension. It represents a group of patients that are at risk
for developing pulmonary arterial hypertension.
The administration of ambrisentan is the experimental part of this study. Ambrisentan has not
been approved by the FDA for use of improving right ventricle function in people with
pre-pulmonary arterial hypertension. You will still receive your normal clinical care.
The purpose of this study is to learn more about ambrisentan and its role in treating
systemic sclerosis-associated pre-pulmonary arterial hypertension. Ambrisentan is already
approved for use in people with systemic sclerosis-associated pulmonary arterial
hypertension, but this study wants to research its role in people with pre-pulmonary arterial
hypertension.
Inclusion Criteria:
- Age >18 years, < 80 years
- Systemic sclerosis with any of the following features:
1. Duration of Raynaud's phenomena >8 years
2. Anticentromere antibody positivity
3. isolated nucleolar-pattern ANA positivity
4. Extensive telangiectasias
5. DLCO < 60% in the absence of extensive ILD
6. FVC%/DLCO% >1.6
7. 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
Exclusion Criteria:
- < 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
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