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

Completed

• Conditions: Heart Failure
• Interventions: Drug: sacubitril/valsartan

• Registration Number: NCT02957409
• Lead Sponsor: Novartis Pharmaceuticals

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.

Study Timeline

• Study Start: 2016-05-20
• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-06
• Primary Completion: 2020-10-24
• Study Completion: 2020-10-24
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1009

Inclusion Criteria

• Receiving sacubitril/valsartan as per the Canadian product label and treatment initiation within the last 3 months
• Able to communicate with investigator

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sacubitril/valsartan	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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.
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.
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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇦 Quebec, Canada