Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH

ConditionCTEPH
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorDr Sudarshan Rajagopal

About this trial

The main goal of this study is to determine the effects of combination medical therapy (Riociguat and Macitentan) and balloon pulmonary angioplasty (BPA) on hemodynamics and right ventricular (RV) function (including advanced assessments of RV-pulmonary artery (PA) coupling from invasive hemodynamics) in participants with inoperable or post-PTE residual CTEPH.

Eligibility criteria

Qualifiers

Age ≥ 18 years' old

Diagnosis of CTEPH

Not a candidate for PTE

Candidate for BPA based on suitable anatomy and disease burden

Disqualifiers

Moderate to severe heart disease (LVEF < 45% or severe LV Hypertrophy)

Sarcoidosis

Active cancer

Sickle cell anemia

Trial design

Treatments tested in this trial

  • Macitentan Tablets
  • Riociguat
  • balloon pulmonary angioplasty

Treatment groups

15 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dr Sudarshan Rajagopal

Lead sponsor

Duke University

Sponsor institution

Janssen Pharmaceutica N.V., Belgium

Collaborator