Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH
NCT ID: NCT05140525
Last Updated: 2025-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
15 participants
INTERVENTIONAL
2025-01-27
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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participants with inoperable CTEPH
subject with inoperable Chronic thromboembolic Pulmonary Hypertension
Macitentan Tablets
10 mg oral once daily
Riociguat
1 mg to 2.5mg oral three times daily
balloon pulmonary angioplasty
on hemodynamics and RV function (including advanced assessments of RV-PA coupling
post PTE residual CTEPH
Subject with post pulmonary endarterectomy (PTE) residual Chronic Thromboembolic Pulmonary Hypertension
Macitentan Tablets
10 mg oral once daily
Riociguat
1 mg to 2.5mg oral three times daily
balloon pulmonary angioplasty
on hemodynamics and RV function (including advanced assessments of RV-PA coupling
Interventions
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Macitentan Tablets
10 mg oral once daily
Riociguat
1 mg to 2.5mg oral three times daily
balloon pulmonary angioplasty
on hemodynamics and RV function (including advanced assessments of RV-PA coupling
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of CTEPH
3. Not a candidate for PTE
4. Candidate for BPA based on suitable anatomy and disease burden
5. 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.
6. Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed).
Exclusion Criteria
1. Moderate to severe heart disease (LVEF \< 45% or severe LV Hypertrophy)
2. Sarcoidosis
3. Active cancer
4. Sickle cell anemia
5. Liver disease (Childs-Pugh class C)
6. Prisoners
7. Pregnant, planning pregnancy or lactating
8. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
9. Contraindication to riociguat or macitentan
10. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
18 Years
ALL
No
Sponsors
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Janssen Pharmaceutica N.V., Belgium
INDUSTRY
Dr Sudarshan Rajagopal
OTHER
Responsible Party
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Dr Sudarshan Rajagopal
Associate Professor of Medicine
Principal Investigators
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Sudarshan Rajagopal, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke Health System
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00105903
Identifier Type: -
Identifier Source: org_study_id
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