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Clinical Trial 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.


Clinical Trial Description

Recent presented but unpublished results from trials of BPA vs riociguat for inoperable CTEPH (NCT02634203) have demonstrated that BPA provides a more significant hemodynamic benefit than medical therapy. The investigators hypothesize that participants who are treated with upfront combination medical therapy followed by BPA will have significant improvements in their hemodynamics and RV-PA coupling that can be monitored over time. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05140525
Study type Interventional
Source Duke University
Contact David Ptashnik, MS
Phone 9196682642
Email david.ptashnik@duke.edu
Status Not yet recruiting
Phase Phase 3
Start date May 31, 2024
Completion date July 31, 2024

See also
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Completed NCT04730037 - Clinical Trial to Investigate Safety and Efficacy of Edoxaban in Patients With CTEPH (KABUKI) Phase 3
Completed NCT03245268 - International BPA Registry
Recruiting NCT02660463 - Prospective Registry to Evaluate the Effective Incidence of Chronic Thromboembolic Pulmonary Hypertension in Germany N/A
Completed NCT01393327 - Feasibility and Influence of Exercise Therapy on Oxygen Uptake and Right Heart Function in CTEPH Patients After PEA N/A
Recruiting NCT01672203 - Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Incidence in Patients With Central Versus Peripheral Embolism N/A
Completed NCT03953560 - Symptom-related Screening for Early Detection of CTEPH. N/A
Completed NCT02656238 - New International CTEPH Database
Recruiting NCT05480137 - OCT Evaluates the Effects of CTEPH Treated by Scoring Balloon N/A
Terminated NCT03273257 - Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study) Phase 2
Recruiting NCT05629052 - TrEatment Approach in the Multimodal Era Registry
Completed NCT04207593 - The Effect of Oxygen Therapy on 6MWD in PAH and CTEPH Patients With Hypoxemia Phase 2