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

Study category: Heart and Blood Conditions

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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

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Todd Bull,  MD

Todd Bull, MD

Study ID

Protocol Number: 17-2349

ClinicalTrials.gov: NCT03409588

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