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Aquaman: Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendoarterectomy

Primary Objective

To determine if the chronic administration of riociguat improves exercise hemodynamic profiles measured by tight heart catheterization (RHC) - in patients with subjective exercise limitation at least 6 months post-PTE surgery.

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Description

This is a 3 month study to see if riociguat improves RHC measurements and exercise tolerance. There are 2 study visits - one at the beginning and one at the end - during which the subject will undergo a 6 MWT as well as a resting RHC and an exercise RHC. Study drug will be uptitrated at week 2, 4 and 6 via the telephone.

Details
Age
Adult
Eligibility
1) Men and Women 18-80 years of age 2) Women cannot be pregnant or nursing and must be willing to use 2 forms of birth control during the study 3) Participants must have undergone PTE surgery for a diagnosis of CTEPH at least 6 months prior to screening and report having continued exercise limitation post PTE surgery. 4) Patients with known residual PH by RHC will be excluded (mP AP > 25 mmHg or a mPAP >30 mmHg and a PVR > 3.00 wu). 5) Patient cannot be currently using revatio or tadalafil
Locations

Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Todd Bull

Todd Bull

Study ID

Protocol Number: 17-2349

More information available at ClinicalTrials.gov: NCT03409588

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