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

NCT ID: NCT03409588

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-13

Study Completion Date

2026-01-26

Brief Summary

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

Detailed Description

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Conditions

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Chronic Thromboembolic Disease (CTED) Exercise Intolerance Post PEA Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Drug

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

Group Type EXPERIMENTAL

Adempas

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Riociguat

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Todd Bull, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Peter Sottile, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

William Cornwell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado, Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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17-2349

Identifier Type: -

Identifier Source: org_study_id

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