Crossover Study From Macitentan or Bosentan Over to Ambrisentan

Phase 4TerminatedNCT02885012

Medical University of South Carolina3 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Arterial Hypertension

Interventions

AmbrisentanDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Ochsner Medical Center

New Orleans, Louisiana, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 24 Weeks

Secondary Outcomes

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.

Time frame: Baseline and 24 Weeks

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.

Time frame: Baseline and 12 Weeks

Data from ClinicalTrials.gov

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