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Completed

NCT Number: NCT02957409

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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Calgary, Alberta, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sacubitril/valsartan

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.

Other names: Entresto

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Relationship between changes in NT-proBNP and all-cause mortality

    Time frame: Up to 3 years

  6. Relationship between changes in NT-proBNP and total all-cause hospitalization

    Time frame: Up to 3 years

  7. Relationship between changes in NT-proBNP and renal impairment

    Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Acronym: PARTHENON

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2016
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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