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

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ClinicalTrials.gov Identifier: NCT03409588
Recruitment Status : Not yet recruiting
First Posted : January 24, 2018
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
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).

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Riociguat

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




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



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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

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
Contact: Cheri Abbott, RN 303-724-7466 Cheryl.Abbott@ucdenver.edu
Contact: Colton Carter, BS 303-724-7938 Colton.Carter@ucdenver.edu

Locations
United States, Colorado
University of Colorado, Anschutz Medical Campus Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Cheri Abbott, RN    303-724-7466    Cheryl.Abbott@ucdenver.edu   
Contact: Colton Carter, BS    303-724-7938    Colton.Carter@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
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

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03409588     History of Changes
Other Study ID Numbers: 17-2349
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases