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

Heart Failure Clinical Trial

— PARTHENON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957409
• Other study ID #: CLCZ696BCA03
• Status: Completed
• Start date: May 20, 2016
• Est. completion date: October 24, 2020

Study information

• Verified date: August 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1009
• Est. completion date: October 24, 2020
• Est. primary completion date: October 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• sacubitril/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.

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Brampton	Ontario
Canada	Novartis Investigative Site	Burlington	Ontario
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Cambridge	Ontario
Canada	Novartis Investigative Site	Chicoutimi	Quebec
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Greenfield Park	Quebec
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Joliette	Quebec
Canada	Novartis Investigative Site	Laval	Quebec
Canada	Novartis Investigative Site	Levis	Quebec
Canada	Novartis Investigative Site	Maple Ridge	British Columbia
Canada	Novartis Investigative Site	Moncton	New Brunswick
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Newmarket	Ontario
Canada	Novartis Investigative Site	North Vancouver	British Columbia
Canada	Novartis Investigative Site	Oakville	Ontario
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Sainte Foy	Quebec
Canada	Novartis Investigative Site	Sarnia	Ontario
Canada	Novartis Investigative Site	Scarborough	Ontario
Canada	Novartis Investigative Site	Sherbrooke	Quebec
Canada	Novartis Investigative Site	St-George	Quebec
Canada	Novartis Investigative Site	St-Jean-sur-Richelieu	Quebec
Canada	Novartis Investigative Site	Sudbury	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Trois-Rivieres	Quebec
Canada	Novartis Investigative Site	Waterloo	Ontario
Canada	Novartis Investigative Site	Weston	Ontario
Canada	Novartis Investigative Site	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Relationship between changes in NT-proBNP and all-cause mortality		Up to 3 years
Secondary	Relationship between changes in NT-proBNP and total all-cause hospitalization		Up to 3 years
Secondary	Relationship between changes in NT-proBNP and renal impairment		Up to 3 years