PAtient RegisTry Assessing Effectiveness and Safety of HEart Failure treatmeNt With LCZ696 acrOss CaNada
Overview
- Phase
- Not Applicable
- Intervention
- sacubitril/valsartan
- Conditions
- Heart Failure
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 1009
- Locations
- 1
- Primary Endpoint
- Rate of all-cause hospitalization or all- cause mortality in relation to NT-proBNP or BNP levels
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
sacubitril/valsartan
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
Intervention: sacubitril/valsartan
Outcomes
Primary Outcomes
Rate of all-cause hospitalization or all- cause mortality in relation to NT-proBNP or BNP levels
Time Frame: 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 Outcomes
- Relationship between changes in NT-proBNP and all-cause mortality(Up to 3 years)
- Percentage of patients with clinically relevant hyperkalemia(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)
- Percentage of patients with clinically relevant renal impairment(Up to 3 years)
- Percentage of patients with clinically relevant symptomatic hypotension(Up to 3 years)
- Percentages of patients having a BNP or NT-proBNP level(Up to 3 years)