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Riociguat in Chronic Thromboembolic Pulmonary Hypertension (CTEPH)


Trial Focus

Trial Focus

Lungs & Respiratory

Objective

        
This is an open-label, uncontrolled long-term surveillance study to assess safety, tolerability, and clinical effects of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment.  The individual dose titration is based on the patient's systolic blood pressure and well-being.  The drug will be given in the range of 1.0mg to 2.5mg three times daily.  This study will provide early access to this drug (prior to FDA approval) for patients.  The study/patient treatment will continue until the medical product is approved and commercially available.  Patients will be followed for safety and tolerability assessments including treatment-emergent adverse events, adverse events leading to discontinuation and serious adverse events.

IRB Protocol #

13-1538

Trial Status

Accepting Participants

Contact

Deb McCollister RN at 720-848-6540 or deb.mccollister@ucdenver.edu

Location

University of Colorado HospitalUniversity of Colorado Hospital

Eligibility and Other Participant Information


Main Inclusion Criteria:
1) Age 18-80
2) Patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
3) mPAP >/= 25mm Hg, PVR >/= 300 dynes, PCWP or LVEDP </= 15mm Hg

Main Exclusion Criteria:
1) Uncontrolled systemic hypertension, left heart failure, uncontrolled atrial fibrillation, coronary artery disease, or symptomatic atherosclerotic disease
2) Clinically relevant hepatic dysfunction and/or renal insufficiency
For more information, please contact the Pulmonary Hypertension Center at 720-848-6518