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8110 Gatehouse Road, Falls Church, VA 22042

A Double-Blind, Placebo-Controlled Trial of Oral Riociguat for Sarcoidosis Associated Pulmonary Hypertension (RioSAPH)

General Information

Age Group

Adult

Status

Active

Protocol Number

N/A

Offered At

Inova Heart and Vascular Institute
Advanced Lung Disease and Transplant Clinic
3300 Gallows Road
Falls Church, VA  22042

Principal Investigator

Steven Nathan, MD

Eligibility Information

  • Patients with diagnosis of sarcoidosis
  • Age ≥ 18 years
  • Life expectancy of at least 2 years
  • Females of reproductive potential (FRP) must have a negative, pre-treatment pregnancy test
  • FRP must obtain monthly pregnancy tests during treatment and one month after treatment discontinuation. Post-menopausal women (defined as no menses for at least 1 year or post-surgical from bilateral oophorectomy) and surgically sterilized women are not required to undergo a pregnancy test.
  • Females of reproductive potential and all non-vasectomized male participants must agree to use reliable contraception when sexually active
  • Subjects (males and females) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least 30 days after the last dose of study drug
  • Willing and able to comply with the protocol, including follow-up visits and examinations

Ineligibility Information

  • Patients with an FVC of less than 30% of predicted during screening visit
  • Patients with severe airway obstruction
  • Patients unable to perform the 6 minute walk test
  • Pregnant women (i.e. positive serum ß-human chorionic gonadotropin test or other signs of pregnancy)
  • Breast feeding women
  • Known significant left heart disease:
    • Pulmonary venous hypertension indicated by baseline pulmonary capillary wedge pressure > 15 mmHg
    • Active state or history of hemoptysis or pulmonary hemorrhage
    • Subjects requiring nitrates for any reason
    • Subject using nitrates within one month of entering study
    • Pulmonary veno-occlusive disease
  • Subjects with underlying medical disorders with an anticipated life expectancy below 2 years (e.g. active cancer disease with localized and/or metastasized tumor)
  • Subjects with hypersensitivity to the investigational drug or any of the excipients
  • Clinical relevant hepatic dysfunction
  • Severe renal insufficiency
  • Excluded therapies and medications, previous and concomitant
    • Specific (e.g. sildenafil or tadalafil) or unspecific phosphodiesterase inhibitors (e.g. dipyridamole, theophylline)
    • NO donors (e.g. nitrates). Single applications of vasoactive drugs in connection with diagnostic vasoreactive testing are allowed.
  • Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)
  • Major surgery within 30 days prior to start of study drug