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

NCT ID: NCT02169752

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2017-05-25

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.

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.

Conditions

Pre-Pulmonary Atrial Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ambrisentan

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Ambrisentan

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Letairis

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Jewish Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brett Fenster, MD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

National Jewish Health

Denver, Colorado, United States

Countries

United States

Other Identifiers

HS-2716

Identifier Type: -

Identifier Source: org_study_id