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

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ClinicalTrials.gov Identifier: NCT02957409
Recruitment Status : Active, not recruiting
First Posted : November 7, 2016
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment
Heart Failure Drug: sacubitril/valsartan

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1009 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: PAtient RegisTry Assessing Effectiveness and Safety of HEart Failure treatmeNt With LCZ696 acrOss CaNada
Actual Study Start Date : May 20, 2016
Estimated Primary Completion Date : October 12, 2020
Estimated Study Completion Date : October 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Valsartan

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 Name: Entresto




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957409


Locations
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Canada, Alberta
Novartis Investigative Site
Calgary, Alberta, Canada, T2N 4Z6
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
Novartis Investigative Site
Maple Ridge, British Columbia, Canada, V2X 2P8
Novartis Investigative Site
North Vancouver, British Columbia, Canada, V7M 2H4
Canada, Manitoba
Novartis Investigative Site
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, New Brunswick
Novartis Investigative Site
Moncton, New Brunswick, Canada, E1G 1A7
Canada, Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Novartis Investigative Site
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
Canada, Quebec
Novartis Investigative Site
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
Canada
Novartis Investigative Site
Quebec, Canada, G1R 2J6
Sponsors and Collaborators
Novartis Pharmaceuticals

Additional Information:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02957409     History of Changes
Other Study ID Numbers: CLCZ696BCA03
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Heart failure
Heart Failure with Reduced Ejection Fraction
HFrEF
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Valsartan
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action