Heart Failure
Conditions
Keywords
Heart failure, Heart Failure with Reduced Ejection Fraction, HFrEF
Brief summary
The purpose of the study is to describe the heart failure with reduced ejection fraction (HFrEF) patient population receiving sacubitril/valsartan treatment.
Detailed description
The purpose of the study is to describe the heart failure with reduced ejection fraction (HFrEF) patient population receiving sacubitril/valsartan treatment.
Interventions
DRUGsacubitril/valsartan
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.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of all-cause hospitalization or all- cause mortality in relation to NT-proBNP or BNP levels | Up to 3 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with clinically relevant hyperkalemia | Up to 3 years | Hyperkalemia defined as serum potassium \>5.5 mmol/L \[mEq/L\] after a repeated measure within one week to confirm serum potassium elevation. |
| Percentage of patients with clinically relevant renal impairment | Up to 3 years | 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. |
| Percentages of patients having a BNP or NT-proBNP level | Up to 3 years | 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. |
| Percentage of patients with clinically relevant symptomatic hypotension | Up to 3 years | 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. |
| 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 | — |
| Relationship between changes in NT-proBNP and all-cause mortality | Up to 3 years | — |
Countries
Canada
Outcome results
None listed