PROVE-HF

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6724151/?report=classic

Design

• Phase 4, 52-week, Open-label, Single-group study performed at 78 sites in the United States

Population

Inclusion Criteria

• Aged >= 18 years
• Patients with HFrEF who are candidates for on-label sacubitril/valsartan treatment per the standard of care
• NYHA Functional Class II, III, or IV
• LVEF <=40% within the preceding 6 months according to any local measurement, and no subsequent documentation of EF >40%
  • For EF measurements expressed as ranges, the average of the range endpoint valvues should be <40%
• Stable dose of loop diuretic for the 2 weeks preceding study start

Exclusion Criteria

• Hx of hypersensitivity/allergy or suspected contraindication to any study-drug component or to drugs of similar chemical classes, including ACEIs, Angiotensin receptor blockers, or neprilysin inhibitors
• Any angioedema hx (Drug related or otherwise)
• Concomitant use of ACEI therapy, nesiritide, aliskiren, or drugs that may affect absorption of the study medication
• Current or previous treatment with sacubitril/valsartan
• Inadequate washout of other investigational drugs before study initiation
• Enrollment in another clinical trial within 30 days of screening
• Potassium > 5.2 mEq/L at screening
• Hx of malignancy within 1 year
• Pregnancy, lactation, or use of any method of contraception that is not highly effective
• Implantation of CRT/D within 6 months of screening visit
• Prior Heart transplant or Left-ventricular assist device or intent to implant either

Outcomes

Comparisons are intensive therapy vs. standard therapy.