PAtient RegisTry Assessing Effectiveness and Safety of HEart Failure treatmeNt With LCZ696 acrOss CaNada

Study Overview
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Brief Summary
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The purpose of the study is to describe the heart failure with reduced ejection fraction (HFrEF) patient population receiving sacubitril/valsartan treatment.

Detailed Description
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The purpose of the study is to describe the heart failure with reduced ejection fraction (HFrEF) patient population receiving sacubitril/valsartan treatment.

Official Title
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PAtient RegisTry Assessing Effectiveness and Safety of HEart Failure treatmeNt With LCZ696 acrOss CaNada

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: sacubitril/valsartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving sacubitril/valsartan as per the Canadian product label and treatment initiation within the last 3 months Able to communicate with investigator Exclusion Criteria: Participation in a clinical trial of an investigational drug, concurrently, or within the last 30 days Presence of any condition that in the opinion of the investigator, prohibits patient from participating in the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sacubitril/valsartan<br>Patients diagnosed with HFrEF being treated with sacubitril/valsartan according to the Canadian product label and treatment initiation with sacubitril/valsartan within the last 3 months. The usual recommended starting dose is one tablet of 49 mg sacubitril / 51 mg valsartan taken twice daily. The target dose is one tablet of 97 mg sacubitril / 103 mg valsartan taken twice daily. Investigator/designated will document sacubitril/valsartan treatment adherence throughout the 3 years study period | Drug: sacubitril/valsartan<br>* 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.<br>* Other names: Entresto;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Up to 3 years | 
| Relationship between changes in NT-proBNP and all-cause mortality |  | Up to 3 years | 
| Relationship between changes in NT-proBNP and total all-cause hospitalization |  | Up to 3 years | 
| Relationship between changes in NT-proBNP and renal impairment |  | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Heart Failure with Reduced Ejection Fraction, HFrEF