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

Chronic Thromboembolic Disease (CTED) Clinical Trial

Official title:

Treatment of Exercise-Induced Pulmonary Vascular Dysfunction in Symptomatic Patients After Pulmonary Thromboendarterectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03409588
• Other study ID #: 17-2349
• Status: Recruiting
• Phase: Phase 2
• Start date: June 13, 2018
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Cheri Abbott, RN
• Phone: 303-724-7466
• Email: Cheryl.Abbott[@]ucdenver.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Thromboembolic Disease (CTED)
• Exercise Intolerance Post PEA Surgery
• Thromboembolism

Intervention

Drug:
• Adempas
After obtaining baseline data, patients will be placed on oral riociguat at a dose of 0.5 mg TID which will be up titrated over two months to a maximum dose of 2.5 mg TID or maximum tolerated dose. After 3 months from onset of riociguat initiation, the University of California San Diego (UCSD) shortness of breath score, 6 Minute Walk Test (6MWD), and resting/exercise Right Heart Catheterization (RHC) will be repeated.

Locations

Country	Name	City	State
United States	University of Colorado, Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean pulmonary arterial pressure	Measurements include mPAP (mean pulmonary arterial pressure) measured by right heart catheterization (RHC)	Baseline and 3 months
Primary	Change in cardiac output	Measurements include CO (cardiac output) mPAP/CO slope measured by right heart catheterization (RHC)	Baseline and 3 months
Primary	Change in Pulmonary artery compliance	Measurements include Pulmonary artery compliance measured by right heart catheterization (RHC)	Baseline and 3 months
Secondary	Change in 6 minute walk test	Measurements include change in 6 minute walk test (6 MWT) following 3 months of study drug	Baseline and 3 months
Secondary	Change in New York Heart Association (NYHA) functional class	Measurements include Change in New York Heart Association (NYHA) functional class following 3 months of study drug	Baseline and 3 months
Secondary	Change in the University of California San Diego (UCSD) shortness of Breath Score	Measurements include: Change in the University of California San Diego (UCSD) shortness of Breath Score following 3 months of study drug	Baseline and 3 months