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

Information source: National Jewish Health
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pre-Pulmonary Atrial Hypertension

Intervention: Ambrisentan (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: National Jewish Health

Official(s) and/or principal investigator(s):
Brett Fenster, MD, Principal Investigator, Affiliation: National Jewish Health

Overall contact:
Valerie Snyder, Phone: 303-270-2591, Email: snyderv@njhealth.org

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Improvement in right ventricular (RV) myocardio strain > 2%

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Valerie Snyder, Phone: 303-270-2591, Email: snyderv@njhealth.org

National Jewish Health, Denver, Colorado 80206, United States; Recruiting
Valerie Snyder, Phone: 303-270-2591, Email: synderv@njhealth.org
Brett Fenster, MD, Principal Investigator
Additional Information

Starting date: September 2012
Last updated: June 19, 2014

Page last updated: August 23, 2015

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