An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Patients With Exercise Induced Pulmonary Arterial Hypertension
Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Exercised Induced Pulmonary Arterial Hypertension
Intervention: ambrisentan (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Brigham and Women's Hospital Official(s) and/or principal investigator(s): Aaron Waxman, MD, PhD, Principal Investigator, Affiliation: Brigham and Women's Hospital
Overall contact: Laurie Lawler, RN, Phone: 617-525-9731, Email: llawler@partners.org
Summary
The purpose of this study is asses whether ambrisentan can help people with Exercised
Induced Pulmonary Arterial Hypertension. The investigators also want to find out if
ambrisentan is safe to take without causing excessive side effects.
Clinical Details
Official title: An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Patients With Exercise Induced Pulmonary Arterial Hypertension
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The proportion of subjects who achieve categorical improvement will be assessed by a change from baseline in Advanced Level-3 Cardiopulmonary Exercise Test (CPET) to Week 24.
Secondary outcome: A change from baseline in 6-minute walk distance
Detailed description:
Exercised Induce Pulmonary Arterial Hypertension (EIPAH) population: These patients may
provide a unique window into the pathogenesis of PAH. Our data suggest that these patients
may represent an early phase of PAH with an abnormal vascular response.
The study includes an assessment of the potential impact of ambrisentan on exercise capacity
Advanced Level-3 CPET, and New York Heart Association (NYHA) functional class.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- The subject provides written informed consent before the commencement of any study
related procedure.
- The subject is 18 years of age or older.
- If a female subject of child-bearing potential, the subject must agree to use 2 forms
of contraceptive therapy, including at least 1 barrier method, throughout the study
and follow-up. (Women who are surgically sterile or those post-menopausal for at
least 2 years are not considered to be of childbearing potential.)
- The subject has findings of either exercise induced PAH on a Advanced Level -3 CPET
performed within the last 6-months and is a NYHA Class I or II.
- The subject has an LVEF 55%, obtained by any appropriate method (i. e., ECHO,
radionuclide imaging, or cardiac catheterization)
- The subject is taking a stable concomitant medication regimen for at least 4 weeks
prior to enrollment in the study that is not expected to change during the study
period and follow-up. Changes in diuretic and/or nitrate therapy as needed during the
study period are acceptable.
Locations and Contacts
Laurie Lawler, RN, Phone: 617-525-9731, Email: llawler@partners.org
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting Laurie Lawler, RN, Phone: 617-525-9731, Email: llawler@partners.org Aaron Waxman, MD, PhD, Principal Investigator
Additional Information
Starting date: September 2008
Last updated: July 23, 2014
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