Cardiovascular, Renal & Metabolism
- Studies with sac/val in Chronic Heart Failure with reduced ejection fraction (EF):
- Safety and tolerability in populations not well represented in PARADIGM-HF, PIONEER-HF
- de-novo heart failure
- ACEi/ARB naive
- Safety and tolerability in populations not well represented in PARADIGM-HF, PIONEER-HF
- Mechanistic studies looking at:
- Remodeling, fibrosis, inflammation
- Cardiac function (including diastolic function)
- Cardiac biomarkers
- Population with specific, less well studied / documented HF etiologies
- Out of scope :
- Studies in HFmREF or HFpEF or post-MI patients
- Comparative effectivenes studies vs other MoA, e.g. SGLT-2i
- Studies in non-cardiovascular disease
- Studies in patients with valvular disorders not related to HF
- Studies focused on hypertension including resistant hypertension
- Studies in patients with severe renal impairment (eGFR < 30 ml/min/1.73 m2)
- Studies in children (<18 years)