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

NCT02169752 | Terminated DMC

• 1 other identifier: HS-2716
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Pulmonary Atrial Hypertension

Keywords

Pre-Pulmonary Atrial Hypertension

Outcome Measures

Primary Outcomes (1)

• Improvement in right ventricular (RV) myocardio strain > 2%

  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.

  1, 3 and 6 months

Study Arms (2)

Ambrisentan

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Ambrisentan 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.

Also known as: Letairis

Ambrisentan; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Jewish Health: lead

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

MeSH Terms

Interventions

ambrisentan

Study Officials

• Brett Fenster, MD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: June 23, 2014
• Study Start: September 1, 2012
• Primary Completion: May 25, 2017
• Study Completion: May 25, 2017
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

US (1)