Crossover Study From Macitentan or Bosentan Over to Ambrisentan
- Registration Number
- NCT02885012
- Lead Sponsor
- Medical University of South Carolina
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Switch to Letairis from Bosentan Ambrisentan Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis) Switch to Letairis from Macitentan Ambrisentan Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis)
- Primary Outcome Measures
Name Time Method Change in Stroke Volume 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 Outcome Measures
Name Time Method Change in EmPHasis-10 Score Baseline and 24 Weeks Questionnaire-. The questionnaire is designed to determine how pulmonary hypertension affects the patient's life by asking 10 questions which address breathlessness, fatigue, control, and confidence. emPHasis-10 consists of 10 items which address breathlessness, fatigue, control and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life.
Disease Status as Measured by Change in Biomarker Baseline and 12 Weeks NT-proBNP Biomarker: BNP is released from cardiac cells in response to increased pressure. The higher the value the worse the disease status.
Trial Locations
- Locations (2)
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States