Crossover Study From Macitentan or Bosentan Over to Ambrisentan

Pulmonary Arterial Hypertension Clinical Trial

— Letairis  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02885012
• Other study ID #: 00046009
• Status: Terminated
• Phase: Phase 4
• Start date: June 2016
• Est. completion date: July 7, 2017

Study information

• Verified date: April 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 7, 2017
• Est. primary completion date: July 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Ambrisentan
At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Ochsner Medical Center	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Ochsner Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Stroke Volume	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.	Baseline and 24 Weeks
Secondary	Change in EmPHasis-10 Score	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.	Baseline and 24 Weeks
Secondary	Disease Status as Measured by Change in Biomarker	NT-proBNP Biomarker: BNP is released from cardiac cells in response to increased pressure. The higher the value the worse the disease status.	Baseline and 12 Weeks