Clinical Trials

Inclusion Criteria:

- Signed informed consent

- On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety
issue

Exclusion Criteria:

- Subject only participated in PANORAMA-HF Part 1 or was a SF in PANORAMA-HF or
permanently discontinued study drug in PANORMA-HF Part 2

- Use of investigational drugs within 5 half-lives of enrollment or within 30 days
(longer duration); with the exception of PANORAMA-HF study drug (requires >/=36-hour
washout before baseline visit)

- History of hypersensitivity or allergy to study treatment, its excipients or drugs of
similar chemical class, ACEIs, ARBs, or NEP inhibitor and known/suspected
contraindications to sacubitril/valsartan

- Renal vascular hypertension (including renal artery stenosis)

- Significant renal estimated glomerular filtration rate disorder (eGFR calculated using
modified Schwartz formula <30% mean GFR for age); hepatic disorder (serum aspartate
aminotransferase or alanine aminotransferase > 3 times upper limit of normal);
gastrointestinal disorder or biliary disorder

- History of angioedema

- Parents or legal guardians of subject who do not give consent or allow the child to
give assent, or inability of patient or parents/legal guardians to follow instructions
or comply with follow-up procedures

- Any medical condition(s) that may put the patient at risk in the investigator's
opinion or that the investigator deems unsuitable for the study

- Other protocol defined inclusion/exclusion criteria may apply

Eligibility last updated 7/26/22. Questions regarding updates should be directed to the study team contact.