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

August 24, 2021 updated by: Novartis Pharmaceuticals
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1009

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of all-cause hospitalization or all- cause mortality in relation to NT-proBNP or BNP levels
Time Frame: Up to 3 years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of patients with clinically relevant symptomatic hypotension
Time Frame: Up to 3 years
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
Time Frame: Up to 3 years
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
Time Frame: Up to 3 years
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
Time Frame: Up to 3 years
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
Time Frame: Up to 3 years
Up to 3 years
Relationship between changes in NT-proBNP and total all-cause hospitalization
Time Frame: Up to 3 years
Up to 3 years
Relationship between changes in NT-proBNP and renal impairment
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 24, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLCZ696BCA03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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