PAtient RegisTry Assessing Effectiveness and Safety of HEart Failure treatmeNt With LCZ696 acrOss CaNada
PARTHENON
1 other identifier
observational
1,009
1 country
32
Brief Summary
The purpose of the study is to describe the heart failure with reduced ejection fraction (HFrEF) patient population receiving sacubitril/valsartan treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2016
Longer than P75 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2016
CompletedFirst Submitted
Initial submission to the registry
November 3, 2016
CompletedFirst Posted
Study publicly available on registry
November 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2020
CompletedAugust 26, 2021
August 1, 2021
4.4 years
November 3, 2016
August 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Percentage of patients with clinically relevant symptomatic hypotension
Up to 3 years
Percentage of patients with clinically relevant hyperkalemia
Up to 3 years
Percentage of patients with clinically relevant renal impairment
Up to 3 years
Percentages of patients having a BNP or NT-proBNP level
Up to 3 years
Relationship between changes in NT-proBNP and all-cause mortality
Up to 3 years
- +2 more secondary outcomes
Study Arms (1)
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
Interventions
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.
Eligibility Criteria
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
You may qualify if:
- Receiving sacubitril/valsartan as per the Canadian product label and treatment initiation within the last 3 months
- Able to communicate with investigator
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Novartis Investigative Site
Calgary, Alberta, T2N 4Z6, Canada
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Edmonton, Alberta, T6G 2C8, Canada
Novartis Investigative Site
Maple Ridge, British Columbia, V2X 2P8, Canada
Novartis Investigative Site
North Vancouver, British Columbia, V7M 2H4, Canada
Novartis Investigative Site
Winnipeg, Manitoba, R2H 2A6, Canada
Novartis Investigative Site
Moncton, New Brunswick, E1G 1A7, Canada
Novartis Investigative Site
Halifax, Nova Scotia, B3H 3A7, Canada
Novartis Investigative Site
Brampton, Ontario, L6W 2X7, Canada
Novartis Investigative Site
Burlington, Ontario, L7M 4Y1, Canada
Novartis Investigative Site
Cambridge, Ontario, N1R 6V6, Canada
Novartis Investigative Site
Greater Sudbury, Ontario, P3E 5M9, Canada
Novartis Investigative Site
Newmarket, Ontario, L3Y 2P6, Canada
Novartis Investigative Site
Oakville, Ontario, L6K 3W7, Canada
Novartis Investigative Site
Sarnia, Ontario, N7T 4X3, Canada
Novartis Investigative Site
Scarborough Village, Ontario, M1P 2V5, Canada
Novartis Investigative Site
Toronto, Ontario, M5G 2N2, Canada
Novartis Investigative Site
Waterloo, Ontario, N2T 0C1, Canada
Novartis Investigative Site
Weston, Ontario, M9N 1W4, Canada
Novartis Investigative Site
Chicoutimi, Quebec, G7H 5H6, Canada
Novartis Investigative Site
Greenfield Park, Quebec, J4V 2G8, Canada
Novartis Investigative Site
Joliette, Quebec, J6E 6J2, Canada
Novartis Investigative Site
Laval, Quebec, H7M 3L9, Canada
Novartis Investigative Site
Lévis, Quebec, G6V 4Z5, Canada
Novartis Investigative Site
Montreal, Quebec, H1T 1C8, Canada
Novartis Investigative Site
Montreal, Quebec, H3G 1A4, Canada
Novartis Investigative Site
Québec, Quebec, G1R 2J6, Canada
Novartis Investigative Site
Saint-Jean-sur-Richelieu, Quebec, J3A 1J2, Canada
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4G5, Canada
Novartis Investigative Site
Sherbrooke, Quebec, J1H 5N4, Canada
Novartis Investigative Site
St-George, Quebec, G5Y 4T8, Canada
Novartis Investigative Site
Trois-Rivières, Quebec, G8Z 3R9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2016
First Posted
November 7, 2016
Study Start
May 20, 2016
Primary Completion
October 24, 2020
Study Completion
October 24, 2020
Last Updated
August 26, 2021
Record last verified: 2021-08