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

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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Thromboembolic Disease (CTED); Exercise Intolerance Post PEA Surgery
• Intervention / Treatment: Drug: Adempas

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cheri Abbott, RN; Phone Number: 303-724-7466; Email: Cheryl.Abbott@ucdenver.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado, Anschutz Medical Campus
      • Contact: Cheri Abbott, RN; Phone Number: 303-724-7466; Email: Cheryl.Abbott@ucdenver.edu
      • Sub-Investigator: Peter Sottile, MD
      • Sub-Investigator: William Cornwell, MD
      • Principal Investigator: Todd Bull, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study Drug; Riociguat (Adempas) 0.5mg to 2.5 mg three time daily - oral medication

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.; Other Names: Riociguat

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Bayer
• Investigators: Principal Investigator: Todd Bull, MD, University of Colorado, Denver; Principal Investigator: Peter Sottile, MD, University of Colorado, Denver; Principal Investigator: William Cornwell, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2018
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 17, 2018
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Thromboembolic Disease; CTED; Treatment Post PEA surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Activators; Riociguat
• Other Study ID Numbers: 17-2349

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No