Clinical trial NCT02957409: PAtient RegisTry Assessing Effectiveness and Safety of HEart Failure treatmeNt With LCZ696 acrOss CaNada
Official title: PAtient RegisTry Assessing Effectiveness and Safety of HEart Failure treatmeNt With LCZ696 acrOss CaNada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart failure
Heart Failure with Reduced Ejection Fraction
HFrEF
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-11-06
Enrollment: 1009
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with HFrEF being treated with sacubitril/valsartan according to the Canadian product label. Patients are being followed/treated by Cardiologist and General Practitioners from academic institution, institution and clinic

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.

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

Primary outcomes:
measure: Rate of all-cause hospitalization or all- cause mortality in relation to NT-proBNP or BNP levels
timeFrame: Up to 3 years
Secondary outcomes:
measure: Percentage of patients with clinically relevant symptomatic hypotension
timeFrame: Up to 3 years
measure: Percentage of patients with clinically relevant hyperkalemia
timeFrame: Up to 3 years
measure: Percentage of patients with clinically relevant renal impairment
timeFrame: Up to 3 years
measure: Percentages of patients having a BNP or NT-proBNP level
timeFrame: Up to 3 years
measure: Relationship between changes in NT-proBNP and all-cause mortality
timeFrame: Up to 3 years
measure: Relationship between changes in NT-proBNP and total all-cause hospitalization
timeFrame: Up to 3 years
measure: Relationship between changes in NT-proBNP and renal impairment
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Maple Ridge
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: North Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Novartis Investigative Site
state: Manitoba
city: Moncton
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Brampton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Burlington
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Cambridge
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Newmarket
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Oakville
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Sarnia
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Scarborough
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Sudbury
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Waterloo
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Weston
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Greenfield Park
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Joliette
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Laval
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Levis
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sainte Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: St-George
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: St-Jean-sur-Richelieu
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Novartis Investigative Site
Study officials:
References: