Double blind placebo controlled trial of riociguat for sarcoidosis associated pulmonary hypertension
Study design Patients will be recruited into double blind randomized trial of riociguat with 1:1 active drug to placebo. The table below summarizes the study design. Patients will have previously undergone right heart catheterization (RHC) within six months of initial dose dispensation and with no significant change in treatment for pulmonary hypertension. Patients will initiated on 0.5 mg tid and titrated every 2 weeks to a maximum of 2.5 mg three times a day. The patient will be treated for 48 weeks or until clinical worsening of disease. An adjudication committee will review all cases of clinical worsening. This committee will be blinded to treatment. The determination by the adjudication committee will be used as the final determinant for the primary end point.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
University of Cincinnati
Cincinnati, Ohio, United States
RECRUITINGTime until clinical worsening
Patient shows deterioration using fixed criteria
Time frame: 48 weeks
Safety: adverse events
adverse events
Time frame: 48 weeks
Pulmonary function
Changes in FVC
Time frame: 48 weeks
Quality of life
Changes in QOL using general and sarcoidosis specific instruments
Time frame: 48 weeks
Six minute walk
Change in six minute walk distance
Time frame: 48 weeks
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