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

NCT ID: NCT02957409

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1009 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-20

Study Completion Date

2020-10-24

Brief Summary

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

Detailed Description

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

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

sacubitril/valsartan

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Entresto

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Calgary, Alberta, Canada

Site Status

Novartis Investigative Site

Calgary, Alberta, Canada

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Novartis Investigative Site

Edmonton, Alberta, Canada

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Novartis Investigative Site

Maple Ridge, British Columbia, Canada

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Novartis Investigative Site

North Vancouver, British Columbia, Canada

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Novartis Investigative Site

Winnipeg, Manitoba, Canada

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Novartis Investigative Site

Moncton, New Brunswick, Canada

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Novartis Investigative Site

Halifax, Nova Scotia, Canada

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Novartis Investigative Site

Brampton, Ontario, Canada

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Novartis Investigative Site

Burlington, Ontario, Canada

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Novartis Investigative Site

Cambridge, Ontario, Canada

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Novartis Investigative Site

Greater Sudbury, Ontario, Canada

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Novartis Investigative Site

Newmarket, Ontario, Canada

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Novartis Investigative Site

Oakville, Ontario, Canada

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Novartis Investigative Site

Sarnia, Ontario, Canada

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Novartis Investigative Site

Scarborough Village, Ontario, Canada

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Novartis Investigative Site

Toronto, Ontario, Canada

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Waterloo, Ontario, Canada

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Novartis Investigative Site

Weston, Ontario, Canada

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Novartis Investigative Site

Chicoutimi, Quebec, Canada

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Greenfield Park, Quebec, Canada

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Novartis Investigative Site

Joliette, Quebec, Canada

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Novartis Investigative Site

Laval, Quebec, Canada

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Novartis Investigative Site

Lévis, Quebec, Canada

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Novartis Investigative Site

Montreal, Quebec, Canada

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Novartis Investigative Site

Montreal, Quebec, Canada

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Novartis Investigative Site

Québec, Quebec, Canada

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Novartis Investigative Site

Saint-Jean-sur-Richelieu, Quebec, Canada

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Novartis Investigative Site

Sainte-Foy, Quebec, Canada

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Novartis Investigative Site

Sherbrooke, Quebec, Canada

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Novartis Investigative Site

St-George, Quebec, Canada

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Novartis Investigative Site

Trois-Rivières, Quebec, Canada

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Countries

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Canada

Other Identifiers

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CLCZ696BCA03

Identifier Type: -

Identifier Source: org_study_id

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