Effects of Combination Medical Therapy Followed by Balloon Pulmonary Angioplasty on Right Ventricular-PA Coupling and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension

Who is this study for? Patients with CTEPH
What treatments are being studied? Macitentan+Riociguat+Balloon pulmonary angioplasty
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

• Age ≥ 18 years' old

• Diagnosis of CTEPH

• Not a candidate for PTE

• Candidate for BPA based on suitable anatomy and disease burden

• Treatment-naïve (no CTEPH or pulmonary arterial hypertension (PAH)-specific medical therapies) with plans for initiation of CTEPH/PAH-specific medical therapy and treatment with BPA.

• Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed).

Locations
United States
North Carolina
Duke University Medical Center
RECRUITING
Durham
Contact Information
Primary
David Ptashnik, MS
david.ptashnik@duke.edu
9196682642
Time Frame
Start Date: 2025-01-27
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 15
Treatments
Active_comparator: participants with inoperable CTEPH
subject with inoperable Chronic thromboembolic Pulmonary Hypertension
Active_comparator: post PTE residual CTEPH
Subject with post pulmonary endarterectomy (PTE) residual Chronic Thromboembolic Pulmonary Hypertension
Sponsors
Leads: Dr Sudarshan Rajagopal
Collaborators: Janssen Pharmaceutica N.V., Belgium

This content was sourced from clinicaltrials.gov