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Measuring Outcomes In Patients with Pulmonary Arterial Hypertension not on Active Treatment (MOTION)

Title Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients with Pulmonary Arterial Hypertension not on Active Treatment
Therapeutic Area Pulmonary Hypertension
Principal Investigator Ioana Preston, MD
Min Age 18 Years
Max Age 80 Years
Gender Both
Contact Karen Visnaw, RN
More Information


MOTION is a prospective, multicenter, single-arm, open-label, phase IV trial designed to assess whether riociguat monotherapy will improve patient outcomes in patients with PAH who are not currently on treatment. Following a screening period of up to 14 days, eligible subjects will receive therapy with riociguat during a 10-week titration phase. After reaching their individual optimal dose, subjects will then enter a maintenance phase and remain on this dose for an additional 14 weeks. The total duration of treatment with riociguat is 24 weeks. All enrolled patients who receive at least one dose of study medication will undergo a 30-day safety follow-up after the last dose of study medication.

Study Details

Inclusion Criteria

  • PAH of the following types:
    • Idiopathic
    • Familial
    • Associated with PAH due to:
      • Connective tissue disease
      • Congenital heart disease, but only if the patient underwent surgical repair more than one year before enrollment
      • Anorexigen or amphetamine use
      • Portal hypertension with liver cirrhosis
  • Not treated with PAH-specific pulmonary vasodilator medications within 14 days of Screening (Visit 0)

Exclusion Criteria

  • Pulmonary Hypertension (PH), except for subtypes of WHO Group 1 specified in the Inclusion Criteria
  • Evidence of clinically significant restrictive or obstructive parenchymal lung diseases
  • Patients unable to perform a valid 6MWD test

Study Requirements

  • Your medical history and current illnesses will be reviewed
  • Your current medications will be reviewed
  • Physical examinations
  • The severity of your pulmonary hypertension (WHO functional class) will be assessed
  • Your blood pressure and heart rate will be measured, your body weight and height recorded
  • A urine pregnancy test will be done (only for female subjects with childbearing potential)
  • A lung function test will be performed if you haven’t had them done within the last 180 days (a test to measure how well your lungs work)
  • An Echocardiogram (an ultrasound picture of your heart and lungs) will be performed
  • You will complete a health status questionnaires (SF12, LPH, WLQ8)
  • 6MWD Tests
  • A right heart catheterization if you haven’t had one done within the last 6 months