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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: sacubitril/valsartan

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 Type: Observational
• Enrollment (Actual): 1009

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1R 2J6
    • Novartis Investigative Site
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Novartis Investigative Site
    • Calgary, Alberta, Canada
      • Novartis Investigative Site
    • Edmonton, Alberta, Canada, T6G 2C8
      • Novartis Investigative Site
  • British Columbia
    • Maple Ridge, British Columbia, Canada, V2X 2P8
      • Novartis Investigative Site
    • North Vancouver, British Columbia, Canada, V7M 2H4
      • Novartis Investigative Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • Novartis Investigative Site
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • Novartis Investigative Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Novartis Investigative Site
  • Ontario
    • Brampton, Ontario, Canada, L6W 2X7
      • Novartis Investigative Site
    • Burlington, Ontario, Canada, L7M 4Y1
      • Novartis Investigative Site
    • Cambridge, Ontario, Canada, N1R 6V6
      • Novartis Investigative Site
    • Newmarket, Ontario, Canada, L3Y 2P6
      • Novartis Investigative Site
    • Oakville, Ontario, Canada, L6K 3W7
      • Novartis Investigative Site
    • Sarnia, Ontario, Canada, N7T 4X3
      • Novartis Investigative Site
    • Scarborough, Ontario, Canada, M1P 2V5
      • Novartis Investigative Site
    • Sudbury, Ontario, Canada, P3E 5M9
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M5G 2N2
      • Novartis Investigative Site
    • Waterloo, Ontario, Canada, N2T 0C1
      • Novartis Investigative Site
    • Weston, Ontario, Canada, M9N 1W4
      • Novartis Investigative Site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • Novartis Investigative Site
    • Greenfield Park, Quebec, Canada, J4V 2G8
      • Novartis Investigative Site
    • Joliette, Quebec, Canada, J6E 6J2
      • Novartis Investigative Site
    • Laval, Quebec, Canada, H7M 3L9
      • Novartis Investigative Site
    • Levis, Quebec, Canada, G6V 4Z5
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H1T 1C8
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H3G 1A4
      • Novartis Investigative Site
    • Sainte Foy, Quebec, Canada, G1V 4G5
      • Novartis Investigative Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Novartis Investigative Site
    • St-George, Quebec, Canada, G5Y 4T8
      • Novartis Investigative Site
    • St-Jean-sur-Richelieu, Quebec, Canada, J3A 1J2
      • Novartis Investigative Site
    • Trois-Rivieres, Quebec, Canada, G8Z 3R9
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.; Other Names: Entresto

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Relationship between changes in NT-proBNP and all-cause mortality		Up to 3 years
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2016
• Primary Completion (Actual): October 24, 2020
• Study Completion (Actual): October 24, 2020

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimate): November 6, 2016

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Heart failure; Heart Failure with Reduced Ejection Fraction; HFrEF
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan; Sacubitril and valsartan sodium hydrate drug combination
• Other Study ID Numbers: CLCZ696BCA03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided