Clinical trial

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

Name

17-2349

Description

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

Trial arms

Trial start

2018-06-13

Estimated PCD

2024-12-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Study Drug

Other names:

Riociguat

Size

Primary endpoint

Change in mean pulmonary arterial pressure

Baseline and 3 months

Change in cardiac output

Baseline and 3 months

Change in Pulmonary artery compliance

Baseline and 3 months

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2024-05-23

1 organization

1 product

2 indications

Organization

University of Colorado Denver

Product

Adempas

Indication

Chronic Thromboembolic Disease

Indication

Post PEA Surgery