A Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH)
Overview
- Phase
- Phase 4
- Intervention
- Ambrisentan
- Conditions
- Pulmonary Arterial Hypertension
- Sponsor
- Medical University of South Carolina
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Change in Stroke Volume
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to learn more about the safety and effects of switching treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24 weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension (CTD-PAH).
Detailed Description
The study will consist of a group of subjects who have been on bosentan for at least three months and a group that has been on macitentan for at least three months. Both groups will be switched to Letairis 5mg daily after the bosentan or macitentan therapy for three months and then increased to a dose of Letairis 10mg daily at week 4 if well tolerated.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of a Connective Tissue Disease (CTD)
- •Age range: 18-80 years old
- •Previous Right Heart Catheterization (RHC) demonstrating PAH
- •Forced vital capacity (FVC) greater than 50%
- •Carbon Monoxide Diffusing Capacity (DLCO) greater than 50%
- •World Health Organization (WHO) functional class II or III
- •Able to perform a 6 minute walk test (6MWT)
- •Stable dose of antihypertensive medications
- •Non-pregnant females
- •Have to be currently on stable dose of bosentan for at least 3 months
Exclusion Criteria
- •Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
- •Severe systemic hypertension greater than 170/95
- •Patients with a prior history of cardiovascular disease
- •WHO functional class IV status
- •Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
- •FVC less than 50% of predicted
- •DLCO less than 50% of predicted
Arms & Interventions
Switch to Letairis from Bosentan
Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis)
Intervention: Ambrisentan
Switch to Letairis from Macitentan
Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis)
Intervention: Ambrisentan
Outcomes
Primary Outcomes
Change in Stroke Volume
Time Frame: Baseline and 24 Weeks
Echocardiography is used to estimate the stroke volume, or the amount of blood ejected from the heart with each beat. An average over three beats is used for the estimate and is reported as ml/beat.
Secondary Outcomes
- Change in EmPHasis-10 Score(Baseline and 24 Weeks)
- Disease Status as Measured by Change in Biomarker(Baseline and 12 Weeks)