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

Phase 2

Recruiting

• Conditions: Chronic Thromboembolic Disease (CTED); Exercise Intolerance Post PEA Surgery
• Interventions: Drug: Adempas

• Registration Number: NCT03409588
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-24
• Study Start: 2018-06-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Drug	Adempas	Riociguat (Adempas) 0.5mg to 2.5 mg three time daily - oral medication

Primary Outcome Measures

Name	Time	Method
Change in cardiac output	Baseline and 3 months	Measurements include CO (cardiac output) mPAP/CO slope measured by right heart catheterization (RHC)
Change in mean pulmonary arterial pressure	Baseline and 3 months	Measurements include mPAP (mean pulmonary arterial pressure) measured by right heart catheterization (RHC)
Change in Pulmonary artery compliance	Baseline and 3 months	Measurements include Pulmonary artery compliance measured by right heart catheterization (RHC)

Secondary Outcome Measures

Name	Time	Method
Change in the University of California San Diego (UCSD) shortness of Breath Score	Baseline and 3 months	Measurements include: Change in the University of California San Diego (UCSD) shortness of Breath Score following 3 months of study drug
Change in 6 minute walk test	Baseline and 3 months	Measurements include change in 6 minute walk test (6 MWT) following 3 months of study drug
Change in New York Heart Association (NYHA) functional class	Baseline and 3 months	Measurements include Change in New York Heart Association (NYHA) functional class following 3 months of study drug

Trial Locations

Locations (1)

University of Colorado, Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States