DIRECTION- Discontinuation versus continuation of riociguat monotherapy in chronic thromboembolic pulmonary hypertension successfully treated with balloon pulmonary angioplasty

Condition studied

chronic thromboembolic pulmonary hypertension

Investigational medicinal product(s)

Every trial of Riociguat across our registers →

Eligibility

Primary endpoint

clinical worsening at the longest follow-up: a.death due to any cause, b.hospitalization due to worsening of PH, including: i.Documented right heart failure, OR ii.Need for lung transplantation, OR iii.Need for intravenous diuretics and/or inotropic support, OR iv. Need for parental prostanoids c. decline in 6MWD by ≥15% from baseline, combined with WHO functional class III or IV IV(confirmed on a second test within 7 days and both conditions met)

Endpoint detail

Change from baseline to Months 3, 6,12 and every 6 months until the last enrolled patient has completed the minimum 12-month follow-up in 6MWD, WHO FC, NT-proBNP levels, and quality of life measured by the generic EQ-5D-5L and the disease-specific EmPHasis-10., Change from baseline to Month 12 in right atrial pressure, mPAP, cardiac output and PVR., Health economic outcomes: incremental cost effectiveness ratio (difference in costs/difference in QALYS) of riociguat monotherapy withdrawal for the French public health system., Treatment burden assessed at baseline and Month 12, Occurrence at the longest follow-up (minimum 12 months) of individual components of the primary endpoint