Overview

Crossover Study From Macitentan or Bosentan Over to Ambrisentan

Status:
Terminated
Trial end date:
2017-07-07
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical University of South Carolina
Collaborator:
Ochsner Health System
Treatments:
Ambrisentan
Bosentan
Macitentan
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

- Adequate acoustic images to allow for transthoracic echocardiography to be performed

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