Heart Failure and Pulmonary Hypertension due to Left Heart Disease (WHO Group 2)
Conditions
Brief summary
Change in PVR from baseline to Week 25 compared with placebo, as measured by RHC
Detailed description
Change from baseline to Week 25 in RHC parameters compared with placebo. Parameters include: • mPAP and PAWP. Change from baseline to Week 25 in echocardiographic parameters compared with placebo. Parameters include: • Cardiac output, SV, EF, LVGLS, PASP, RV/LV ratio, RVOT AT, TRV, TAPSE/PASP. • Systemic vascular resistance, Change in 6MWD and KCCQ TSS from baseline to Week 25 compared with placebo. Change in NYHA FC from baseline to Week 25 compared with placebo., Change in serum creatinine, NT-proBNP, cystatin C, and eGFR from baseline to Week 13 and Week 25 compared with placebo., AZD3427 serum PK concentrations., Presence of ADAs and evaluation of ADA titres.
Interventions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in PVR from baseline to Week 25 compared with placebo, as measured by RHC | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 25 in RHC parameters compared with placebo. Parameters include: • mPAP and PAWP. Change from baseline to Week 25 in echocardiographic parameters compared with placebo. Parameters include: • Cardiac output, SV, EF, LVGLS, PASP, RV/LV ratio, RVOT AT, TRV, TAPSE/PASP. • Systemic vascular resistance, Change in 6MWD and KCCQ TSS from baseline to Week 25 compared with placebo. Change in NYHA FC from baseline to Week 25 compared with placebo., Change in serum creatinine, NT-proBNP, cystatin C, and eGFR from baseline to Week 13 and Week 25 compared with placebo., AZD3427 serum PK concentrations., Presence of ADAs and evaluation of ADA titres. | — |
Countries
Austria, Czechia, Denmark, Germany, Italy, Netherlands, Poland, Spain, Sweden
Outcome results
None listed