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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Age ≥ 18 years' old 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 willing to sign a consent form and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed). Who Should NOT Join This Trial: - Subjects presenting with any of the following will not be included in the trials: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Age ≥ 18 years' old 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: * Subjects presenting with any of the following will not be included in the trials: 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

Treatments Being Tested

DRUG

Macitentan Tablets

10 mg oral once daily

DRUG

Riociguat

1 mg to 2.5mg oral three times daily

DEVICE

balloon pulmonary angioplasty

on hemodynamics and RV function (including advanced assessments of RV-PA coupling

Locations (1)

Duke University Medical Center
Durham, North Carolina, United States