Efficacy and safety of NNC0487-0111 compared to placebo on morbidity and mortality in people with heart failure with preserved or mildly reduced ejection fraction and obesity (HF-POLARIS).
Phase 3 – large-scale trial before approval
Conditions:
HFpEF or HFmrEF and obesity
Sponsor: Novo Nordisk A/S
trial.available_in:
БГ
Overview
Trial status: Authorised
Time to first occurrence of a composite HF and MACE endpoint consisting of: CV death, HF hospitalisation or urgent HF visit, Nonfatal MI, Nonfatal stroke, Change in KCCQ-CSS for participants with baseline KCCQ‑CSS score <80 points, Change in eGFR (creatinine and cystatin C‑based CKD‑EPI 2021) for participants with baseline eGFR<60 mL/min/1.73 m2, Time to all-cause death, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI
Time to first occurrence of a composite HF endpoint consisting of: CV death, HF hospitalisation or urgent HF visit
Description
Time to first occurrence of a composite HF and MACE endpoint consisting of: CV death, HF hospitalisation or urgent HF visit, Nonfatal MI, Nonfatal stroke, Change in KCCQ-CSS for participants with baseline KCCQ‑CSS score <80 points, Change in eGFR (creatinine and cystatin C‑based CKD‑EPI 2021) for participants with baseline eGFR<60 mL/min/1.73 m2, Time to all-cause death, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI
Who can participate
Age group: 18-64 years, 65+ years
Gender: Female, Male
Target enrollment: 702 participants