Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty

University of Colorado Denver (CU Denver)

Status and phase: Enrolling; Phase 2

Conditions: Exercise Intolerance Post PEA Surgery; Chronic Thromboembolic Disease (CTED)

Treatments: Drug: Adempas

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03409588

17-2349

Details and patient eligibility

About

This is an open label study of Riociguat in patients with continued exercise intolerance at least 6 months following pulmonary endarterectomy (PEA).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients who underwent PTE or BPA for Chronic thromboembolic pulmonary hypertension (CTEPH) at least six months prior to screening and report ongoing subjective exercise limitation,
• able to give consent
• able to perform a exercise protocol

Exclusion criteria

• Patients with known Residual Pulmonary Hypertension (RPH) by RHC following PTE for CTEPH
• ongoing PAH-specific vasodilator therapy
• known contraindication to riociguat
• a physical limitation to completing an exercise protocol

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Study Drug

Experimental group

Description:

Riociguat (Adempas) 0.5mg to 2.5 mg three time daily - oral medication

Treatment:

Drug: Adempas