Treatment of Exercise-Induced Pulmonary Vascular Dysfunction in Symptomatic Patients After Pulmonary Thromboendarterectomy
Primary Purpose
Chronic Thromboembolic Disease (CTED), Exercise Intolerance Post PEA Surgery
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Adempas
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Thromboembolic Disease (CTED) focused on measuring Chronic Thromboembolic Disease, CTED, Treatment Post PEA surgery
Eligibility Criteria
Inclusion Criteria:
- Adult patients who underwent PTE 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
Sites / Locations
- University of Colorado, Anschutz Medical CampusRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Drug
Arm Description
Riociguat (Adempas) 0.5mg to 2.5 mg three time daily - oral medication
Outcomes
Primary Outcome Measures
Change in mean pulmonary arterial pressure
Measurements include mPAP (mean pulmonary arterial pressure) measured by right heart catheterization (RHC)
Change in cardiac output
Measurements include CO (cardiac output) mPAP/CO slope measured by right heart catheterization (RHC)
Change in Pulmonary artery compliance
Measurements include Pulmonary artery compliance measured by right heart catheterization (RHC)
Secondary Outcome Measures
Change in 6 minute walk test
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
Measurements include Change in New York Heart Association (NYHA) functional class following 3 months of study drug
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
Full Information
NCT ID
NCT03409588
First Posted
January 17, 2018
Last Updated
September 26, 2023
Sponsor
University of Colorado, Denver
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT03409588
Brief Title
Treatment of Exercise-Induced Pulmonary Vascular Dysfunction in Symptomatic Patients After Pulmonary Thromboendarterectomy
Official Title
Treatment of Exercise-Induced Pulmonary Vascular Dysfunction in Symptomatic Patients After Pulmonary Thromboendarterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2018 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Bayer
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open label study of Riociguat in patients with continued exercise intolerance at least 6 months following pulmonary endarterectomy (PEA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Thromboembolic Disease (CTED), Exercise Intolerance Post PEA Surgery
Keywords
Chronic Thromboembolic Disease, CTED, Treatment Post PEA surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Drug
Arm Type
Experimental
Arm Description
Riociguat (Adempas) 0.5mg to 2.5 mg three time daily - oral medication
Intervention Type
Drug
Intervention Name(s)
Adempas
Other Intervention Name(s)
Riociguat
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mean pulmonary arterial pressure
Description
Measurements include mPAP (mean pulmonary arterial pressure) measured by right heart catheterization (RHC)
Time Frame
Baseline and 3 months
Title
Change in cardiac output
Description
Measurements include CO (cardiac output) mPAP/CO slope measured by right heart catheterization (RHC)
Time Frame
Baseline and 3 months
Title
Change in Pulmonary artery compliance
Description
Measurements include Pulmonary artery compliance measured by right heart catheterization (RHC)
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Change in 6 minute walk test
Description
Measurements include change in 6 minute walk test (6 MWT) following 3 months of study drug
Time Frame
Baseline and 3 months
Title
Change in New York Heart Association (NYHA) functional class
Description
Measurements include Change in New York Heart Association (NYHA) functional class following 3 months of study drug
Time Frame
Baseline and 3 months
Title
Change in the University of California San Diego (UCSD) shortness of Breath Score
Description
Measurements include: Change in the University of California San Diego (UCSD) shortness of Breath Score following 3 months of study drug
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients who underwent PTE 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheri Abbott, RN
Phone
303-724-7466
Email
Cheryl.Abbott@ucdenver.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Bull, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Sottile, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Cornwell, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado, Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheri Abbott, RN
Phone
303-724-7466
Email
Cheryl.Abbott@ucdenver.edu
First Name & Middle Initial & Last Name & Degree
Todd Bull, MD
First Name & Middle Initial & Last Name & Degree
Peter Sottile, MD
First Name & Middle Initial & Last Name & Degree
William Cornwell, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Exercise-Induced Pulmonary Vascular Dysfunction in Symptomatic Patients After Pulmonary Thromboendarterectomy
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