Planned and ongoing trials in pulmonary hypertension (PH) due to left heart disease
| Study# | Study drug | Dose | Subjects n | Duration | Population | Primary outcome |
| SERENADE (NCT03153111) | Macitentan | 10 mg once daily | 300 | 52 weeks | LVEF ≥40% and ESC-defined HFpEF; HF hospitalisation within 12 months and/or PAWP or LVEDP >15 mmHg within 6 months; elevated NT-proBNP; PVD or RVD | % change from baseline in NT-proBNP at week 24 |
| SOPRANO (NCT02554903) | Macitentan | 10 mg once daily | 78 | 12 weeks | LVAD within 45 days; PH by RHC with PAWP ≤18 mmHg and PVR >3 WU | PVR ratio of week 12 to baseline |
| DYNAMIC (NCT02744339) | Oral riociguat | 1.5 mg 3 times a day | 114 | 26 weeks | HFpEF; mPAP >25 mmHg and PAWP >15 mmHg | Change in CO |
| Oral treprostinil (NCT03037580) | Oral treprostinil | 310 | 24 weeks | LVEF ≥50%; RHC within 90 days of randomisation; 6MWD >200 m | Change in 6MWD from baseline to week 24 | |
| PASSION (not registered) | Oral tadalafil | 40 mg once daily | 320 | NA | HFpEF; PH with PAWP >15 mmHg and mPAP >25 mmHg and PVR >3 WU | Time to first event defined as HF-associated hospitalisation (independently adjudicated) or death from any cause |
#: ClinicalTrials.gov identifier numbers are provided where possible. LVEF: left ventricular ejection fraction; ESC: European Society of Cardiology; HF: heart failure; pEF: preserved ejection fraction; PAWP: pulmonary arterial wedge pressure; LVEDP: left ventricular end-diastolic pressure; NT-proBNP: N-terminal pro-brain natriuretic peptide; PVD: pulmonary vascular disease; RVD: right ventricular dysfunction; LVAD: left ventricular assist device; RHC: right heart catheterisation; PVR: pulmonary vascular resistance; mPAP: mean pulmonary arterial pressure; CO: cardiac output; 6MWD: 6-min walk distance; NA: not available.