The purpose of the study is to describe the heart failure with reduced ejection fraction (HFrEF) patient population receiving sacubitril/valsartan treatment.
The purpose of the study is to describe the heart failure with reduced ejection fraction (HFrEF) patient population receiving sacubitril/valsartan treatment.
Study Type
OBSERVATIONAL
Enrollment
1,009
This study is designed as an observational, naturalistic, multicenter study in patients being treated with sacubitril/valsartan as per the Canadian product label. Treatment initiation with sacubitril/valsartan must be within the last 3 months. Sacubitril/valsartan will be used as commercially available supplies which are available as Film coated tablets in 3 dosage: 1) 24 mg sacubitril / 26 mg valsartan, 2) 49 mg sacubitril / 51 mg valsartan and 3) 97 mg sacubitril / 103 mg valsartan.
Rate of all-cause hospitalization or all- cause mortality in relation to NT-proBNP or BNP levels
The primary objective is to describe baseline NT- proBNP, or BNP levels, in relation to total all- cause hospitalization or all-cause mortality in patients with HFrEF treated with sacubitril/valsartan
Time frame: Up to 3 years
Percentage of patients with clinically relevant symptomatic hypotension
Symptomatic hypotension as reported by the treating physician and defined, but not limited to, severe dizziness or fainting (syncope), lack of concentration, blurred vision, nausea, cold, clammy pale skin, and rapid shallow breathing.
Time frame: Up to 3 years
Percentage of patients with clinically relevant hyperkalemia
Hyperkalemia defined as serum potassium \>5.5 mmol/L \[mEq/L\] after a repeated measure within one week to confirm serum potassium elevation.
Time frame: Up to 3 years
Percentage of patients with clinically relevant renal impairment
Renal impairment is defined as a decrease in eGFR of ≥40% after evaluation (verified at subsequent visit) of potentially reversible causes of renal dysfunction or end stage renal disease or need for dialysis or renal transplantation.
Time frame: Up to 3 years
Percentages of patients having a BNP or NT-proBNP level
Percentage of patients having a BNP before sacubitril/valsartan initiation will be reported; whereas, percentage of patients having NT-proBNP level at baseline and NTproBNP levels throughout the registry will be reported.
Time frame: Up to 3 years
Relationship between changes in NT-proBNP and all-cause mortality
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Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
Maple Ridge, British Columbia, Canada
Novartis Investigative Site
North Vancouver, British Columbia, Canada
Novartis Investigative Site
Winnipeg, Manitoba, Canada
Novartis Investigative Site
Moncton, New Brunswick, Canada
Novartis Investigative Site
Halifax, Nova Scotia, Canada
Novartis Investigative Site
Brampton, Ontario, Canada
Novartis Investigative Site
Burlington, Ontario, Canada
...and 22 more locations
Time frame: Up to 3 years
Relationship between changes in NT-proBNP and total all-cause hospitalization
Time frame: Up to 3 years
Relationship between changes in NT-proBNP and renal impairment
Time frame: Up to 3 years