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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03409588
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : August 15, 2022
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
University of Colorado, Denver

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

Condition or disease Intervention/treatment Phase
Chronic Thromboembolic Disease (CTED) Exercise Intolerance Post PEA Surgery Drug: Adempas Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Exercise-Induced Pulmonary Vascular Dysfunction in Symptomatic Patients After Pulmonary Thromboendarterectomy
Actual Study Start Date : June 13, 2018
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Riociguat

Arms and Interventions
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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 Name: Riociguat


Outcome Measures
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Primary Outcome Measures :
  1. Change in mean pulmonary arterial pressure [ Time Frame: Baseline and 3 months ]
    Measurements include mPAP (mean pulmonary arterial pressure) measured by right heart catheterization (RHC)

  2. Change in cardiac output [ Time Frame: Baseline and 3 months ]
    Measurements include CO (cardiac output) mPAP/CO slope measured by right heart catheterization (RHC)

  3. Change in Pulmonary artery compliance [ Time Frame: Baseline and 3 months ]
    Measurements include Pulmonary artery compliance measured by right heart catheterization (RHC)


Secondary Outcome Measures :
  1. Change in 6 minute walk test [ Time Frame: Baseline and 3 months ]
    Measurements include change in 6 minute walk test (6 MWT) following 3 months of study drug

  2. Change in New York Heart Association (NYHA) functional class [ Time Frame: Baseline and 3 months ]
    Measurements include Change in New York Heart Association (NYHA) functional class following 3 months of study drug

  3. Change in the University of California San Diego (UCSD) shortness of Breath Score [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409588


Contacts
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Contact: Cheri Abbott, RN 303-724-7466 Cheryl.Abbott@ucdenver.edu

Locations
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United States, Colorado
University of Colorado, Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Cheri Abbott, RN    303-724-7466    Cheryl.Abbott@ucdenver.edu   
Principal Investigator: Todd Bull, MD         
Sub-Investigator: Peter Sottile, MD         
Sub-Investigator: William Cornwell, MD         
Sponsors and Collaborators
University of Colorado, Denver
Bayer
Investigators
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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
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03409588    
Other Study ID Numbers: 17-2349
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: August 15, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of Colorado, Denver:
Chronic Thromboembolic Disease
CTED
Treatment Post PEA surgery
Additional relevant MeSH terms:
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Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
 Riociguat
Enzyme Activators
Molecular Mechanisms of Pharmacological Action