The Impact of ERA Switching on Risk Stratification in Pulmonary Arterial Hypertension
Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Jun 5, 2025
Trial Information
Current as of June 27, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of switching medications in patients with pulmonary arterial hypertension (PAH), a serious condition that affects blood flow in the lungs and can lead to heart problems. Specifically, the trial will look at how changing from one medication called ambrisentan to another called bosentan impacts patients’ health and the way doctors assess their risk levels for complications. Researchers will measure changes in patients' health over a 3-6 month period, focusing on symptoms, physical ability, and potential side effects, especially related to liver health.
To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of PAH, as determined by a specific heart test. They should have switched from taking ambrisentan to bosentan within the last six months. Participants will be monitored closely during the study, and their health will be assessed to see how the medication switch affects their condition. This trial aims to provide valuable insights that could help doctors make better treatment decisions for patients with PAH.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age ≥ 18 years
- • Confirmed diagnosis of pulmonary arterial hypertension (PAH) by right heart catheterization
- • Documented therapeutic switch from ambrisentan (10 mg once daily) to bosentan (125 mg twice daily) within the previous 6 months
- Exclusion Criteria:
- • History of severe hepatic impairment
- • Incomplete clinical or laboratory records that prevent risk score calculation
- • Inability to attend clinical follow-up between 3 and 6 months after medication switch
About University Of Sao Paulo General Hospital
The University of São Paulo General Hospital (Hospital das Clínicas da Universidade de São Paulo) is a leading clinical research institution in Brazil, renowned for its commitment to advancing medical knowledge and patient care. As an academic hospital affiliated with one of the largest and most prestigious universities in Latin America, it integrates clinical practice, education, and research. The hospital conducts a wide array of clinical trials across various medical disciplines, aiming to develop innovative therapies and improve healthcare outcomes. With a multidisciplinary team of healthcare professionals and access to cutting-edge facilities, the University of São Paulo General Hospital is dedicated to fostering scientific advancements and addressing critical health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
São Paulo, Sp, Brazil
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported