Completed

NCT Number: NCT03409588

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

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

Completed

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Key information

Conditions

Chronic Thromboembolic Disease (CTED) Exercise Intolerance Post PEA Surgery

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adempas

Drug

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

Primary outcomes

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)
Change in cardiac output

Time frame: Baseline and 3 months

Measurements include CO (cardiac output) mPAP/CO slope measured by right heart catheterization (RHC)
Change in Pulmonary artery compliance

Time frame: Baseline and 3 months

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

Secondary outcomes

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
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
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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

Bayer

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2026
Study completion: 2026
First posted: Jan 24, 2018
Registry last updated: Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.