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CompletedNCT03409588Updated Feb 5, 2026

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

A Phase 2 interventional study of Adempas in Chronic Thromboembolic Disease (CTED) and Exercise Intolerance Post PEA Surgery, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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

02

Conditions studied

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

Keywords

  • Chronic Thromboembolic Disease
  • CTED
  • Treatment Post PEA surgery
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Study Drug

    Riociguat (Adempas) 0.5mg to 2.5 mg three time daily - oral medication

    Drug: Adempas

Interventions

  • DrugAdempas

    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.

    Also known as: Riociguat

05

What researchers measure

Primary outcomes

  1. Change in mean pulmonary arterial pressure

    Measurements include mPAP (mean pulmonary arterial pressure) measured by right heart catheterization (RHC)

    Time frame: Baseline and 3 months

  2. Change in cardiac output

    Measurements include CO (cardiac output) mPAP/CO slope measured by right heart catheterization (RHC)

    Time frame: Baseline and 3 months

  3. Change in Pulmonary artery compliance

    Measurements include Pulmonary artery compliance measured by right heart catheterization (RHC)

    Time frame: Baseline and 3 months

Secondary outcomes

  1. Change in 6 minute walk test

    Measurements include change in 6 minute walk test (6 MWT) following 3 months of study drug

    Time frame: Baseline and 3 months

  2. 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

    Time frame: Baseline and 3 months

  3. 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

    Time frame: Baseline and 3 months

06

Study locations

1 site
  • University of Colorado, Anschutz Medical Campus
    Aurora, Colorado 80045, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03409588
Lead sponsor
University of Colorado, Denver
Collaborators
Bayer
Responsible party
Sponsor
First posted
Jan 24, 2018
Start date
Jun 13, 2018
Primary completion
Jan 26, 2026
Completion
Jan 26, 2026
Last update
Feb 5, 2026

Study contacts

Todd Bull, MD
principal investigator · University of Colorado, Denver
Peter Sottile, MD
principal investigator · University of Colorado, Denver
William Cornwell, MD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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