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AMERICA-PAH: Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension

Sponsor
National Jewish Health (Other)
Overall Status
Terminated
CT.gov ID
NCT02169752
Collaborator
(none)
7
Enrollment
1
Location
2
Arms
56.7
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
May 25, 2017
Actual Study Completion Date :
May 25, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ambrisentan

Subjects will be randomly assigned in a 1:1 ration according to the computer generated random numbers to receive either placebo (sugar pill) or ambrisentan.

Drug: Ambrisentan
Subjects will be randomized 1:1 ratio according to computer generated random numbers to receive either "placebo" or ambrisentan 5mg daily for one month followed by 10 mg daily for the 5 months in a double-blinded manner.
Other Names:
  • Letairis

    		•
    Placebo Comparator: Placebo

    Subjects will be randomly assigned in a 1:1 ration according to the computer generated random numbers to receive either placebo (sugar pill) or ambrisentan.

    Drug: Ambrisentan
    Subjects will be randomized 1:1 ratio according to computer generated random numbers to receive either "placebo" or ambrisentan 5mg daily for one month followed by 10 mg daily for the 5 months in a double-blinded manner.
    Other Names:
  • Letairis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in right ventricular (RV) myocardio strain > 2% [1, 3 and 6 months]

      Assess for tolerance, gas exchange, and therapeutic benefit, resting oximetry, six minute walk with oximetry, pulmonary function testing with diffusion capacity (DLCO), and functional class will be assessed prior to ambrisentan initiation, and 1,3, and 6 months.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Jewish Health Denver Colorado United States 80206

    Sponsors and Collaborators

    • National Jewish Health

    Investigators

    • Principal Investigator: Brett Fenster, MD, National Jewish Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Jewish Health
    ClinicalTrials.gov Identifier:
    NCT02169752
    Other Study ID Numbers:
    • HS-2716
    First Posted:
    Jun 23, 2014
    Last Update Posted:
    Jan 19, 2021
    Last Verified:
    Jan 1, 2021
    Keywords provided by National Jewish Health
    Pre-Pulmonary Atrial Hypertension
    Additional relevant MeSH terms:
    Pulmonary Arterial Hypertension
    Hypertension
    Ambrisentan

    Study Results

    No Results Posted as of Jan 19, 2021