Heart FailurePARTHENONNCT02957409
PAtient RegisTry Assessing Effectiveness and Safety of HEart Failure treatmeNt With LCZ696 acrOss CaNada
An observational study of Heart Failure, run by Novartis Pharmaceuticals at 32 sites in Canada.
Trial summary
The purpose of the study is to describe the heart failure with reduced ejection fraction (HFrEF) patient population receiving sacubitril/valsartan treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- sacubitril/valsartan
- Type of treatment
- Pill or oral medicine
- How many people
- 1,009 participants
- Where
- 32 sitesCanada
- Study dates
- 20 May 2016to 24 Oct 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Receiving sacubitril/valsartan as per the Canadian product label and treatment initiation within the last 3 months
- Able to communicate with investigator
Who cannot join
- 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
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Canada32 sites
Novartis Investigative Site
Brampton, Ontario, L6W 2X7
Novartis Investigative Site
Burlington, Ontario, L7M 4Y1
Novartis Investigative Site
Calgary, Alberta, T2N 4Z6
Novartis Investigative Site
Calgary, Alberta
Novartis Investigative Site
Cambridge, Ontario, N1R 6V6
Novartis Investigative Site
Chicoutimi, Quebec, G7H 5H6
Novartis Investigative Site
Edmonton, Alberta, T6G 2C8
Novartis Investigative Site
Greater Sudbury, Ontario, P3E 5M9
Novartis Investigative Site
Greenfield Park, Quebec, J4V 2G8
Novartis Investigative Site
Halifax, Nova Scotia, B3H 3A7
Novartis Investigative Site
Joliette, Quebec, J6E 6J2
Novartis Investigative Site
Laval, Quebec, H7M 3L9
Novartis Investigative Site
Lévis, Quebec, G6V 4Z5
Novartis Investigative Site
Maple Ridge, British Columbia, V2X 2P8
Novartis Investigative Site
Moncton, New Brunswick, E1G 1A7
Novartis Investigative Site
Montreal, Quebec, H1T 1C8
Novartis Investigative Site
Montreal, Quebec, H3G 1A4
Novartis Investigative Site
Newmarket, Ontario, L3Y 2P6
Novartis Investigative Site
North Vancouver, British Columbia, V7M 2H4
Novartis Investigative Site
Oakville, Ontario, L6K 3W7
Novartis Investigative Site
Québec, Quebec, G1R 2J6
Novartis Investigative Site
Saint-Jean-sur-Richelieu, Quebec, J3A 1J2
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4G5
Novartis Investigative Site
Sarnia, Ontario, N7T 4X3
Novartis Investigative Site
Scarborough Village, Ontario, M1P 2V5
Novartis Investigative Site
Sherbrooke, Quebec, J1H 5N4
Novartis Investigative Site
St-George, Quebec, G5Y 4T8
Novartis Investigative Site
Toronto, Ontario, M5G 2N2
Novartis Investigative Site
Trois-Rivières, Quebec, G8Z 3R9
Novartis Investigative Site
Waterloo, Ontario, N2T 0C1
Novartis Investigative Site
Weston, Ontario, M9N 1W4
Novartis Investigative Site
Winnipeg, Manitoba, R2H 2A6
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.
Read the detailed description
The purpose of the study is to describe the heart failure with reduced ejection fraction (HFrEF) patient population receiving sacubitril/valsartan treatment.
- Conditions
- Heart Failure
- Being tested
- sacubitril/valsartan
- Keywords
- Heart failure, Heart Failure with Reduced Ejection Fraction, HFrEF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacubitril/valsartanDrug
Also called Entresto
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: sacubitril/valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 3 years
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 years
Relationship between changes in NT-proBNP and all-cause mortality
Measured: Up to 3 years
Relationship between changes in NT-proBNP and total all-cause hospitalization
Measured: Up to 3 years
Relationship between changes in NT-proBNP and renal impairment
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start20 May 2016
- Primary completion24 Oct 2020
- Study completion24 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,009 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957409
- Sponsor's protocol ID
- CLCZ696BCA03
- Acronym
- PARTHENON
- Status last verified
- Aug 2021
- First submitted
- 3 Nov 2016
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAtient RegisTry Assessing Effectiveness and Safety of HEart Failure treatmeNt With LCZ696 acrOss CaNada
- ClinicalTrials.gov ID
- NCT02957409
- Acronym / sponsor ID
- PARTHENON / CLCZ696BCA03
- Conditions
- Heart Failure
- Keywords
- Heart failure, Heart Failure with Reduced Ejection Fraction, HFrEF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,009 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 May 2016 (actual)
- Primary completion
- 24 Oct 2020 (actual)
- Study completion
- 24 Oct 2020 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to describe the heart failure with reduced ejection fraction (HFrEF) patient population receiving sacubitril/valsartan treatment.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sacubitril/valsartan | – | Drug: sacubitril/valsartanPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Receiving sacubitril/valsartan as per the Canadian product label and treatment initiation within the last 3 months
- Able to communicate with investigator
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sacubitril/valsartanAlso: EntrestoThis 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. | Drug | sacubitril/valsartan |
Primary outcome
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
7 secondary outcomes
Percentage of patients with clinically relevant symptomatic hypotension
Time frame: Up to 3 years
Percentage of patients with clinically relevant hyperkalemia
Time frame: Up to 3 years
Percentage of patients with clinically relevant renal impairment
Time frame: Up to 3 years
Percentages of patients having a BNP or NT-proBNP level
Time frame: Up to 3 years
Relationship between changes in NT-proBNP and all-cause mortality
Time frame: Up to 3 years
Relationship between changes in NT-proBNP and total all-cause hospitalization
Time frame: Up to 3 years
Relationship between changes in NT-proBNP and renal impairment
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Novartis Pharmaceuticals at 32 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of all-cause hospitalization or all- cause mortality in relation to NT-proBNP or BNP levels (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.