Heart FailureLOCATE-HFNCT05870709
Real World, Pharmacy-assessed Adherence to New Onset Entresto® (Sacubitril/Valsartan) in Patients With Chronic Heart Failure
An observational study of Heart Failure, run by Novartis Pharmaceuticals.
Trial summary
This is a multicenter, non-interventional, single arm cohort study with prospective collection of primary data via pharmacists in community pharmacies to describe adherence to sacubitril/valsartan in study patients at the end of the study. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- sacubitril/valsartan
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2023to 31 Oct 2024
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with heart failure who pick up their first ambulatory sacubitril/valsartan prescription in approximately 50 participating pharmacies all over Germany.
Who may be able to join
- Patients with first ambulatory sacubitril/valsartan prescription at screening
- Internet enabled device / smartphone (patient or affiliate)
- ≥ 18 years of age
- Written informed consent to participate in the study
Who cannot join
- Depression-related medication, depression-related comorbidities (patient-reported)
- Patients with unstable acute complications or with an advanced illness likely to interfere with participation in this trial as judged by the enrolling pharmacist
- Simultaneous participation in any interventional trial or simultaneous participation in another Novartis-sponsored non-interventional study with sacubitril/valsartan
About this study
Official title: ReaL wOrld, pharmaCy-assessed Adherence to New onseT Entresto® (Sacubitril/Valsartan) in Patients With Chronic Heart Failure - a Prospective Cohort Study (LOCATE-HF)
This is a multicenter, non-interventional, single arm cohort study with prospective collection of primary data via pharmacists in community pharmacies to describe adherence to sacubitril/valsartan in study patients at the end of the study. Eligible patients with newly prescribed sacubitril/valsartan will be observed in pharmaceutical routine.
Read the detailed description
The study duration will last up to about 30 weeks per patient and will consist of a approximately three visits - Baseline visit (V1), week 1-12 (V2) and week 13-30 (V3).
No exact date for visit 2 and visit 3 will be enforced, to avoid interference with usual care.
- Conditions
- Heart Failure
- Being tested
- sacubitril/valsartan
- Keywords
- Heart failure, NIS, Germany, sacubitril, valsartan
- 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/valsartanOther
There is no treatment allocation. Patients with a first ambulatory sacubitril/valsartan prescription who are interested in study participation will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| sacubitril/valsartan | patient with a first ambulatory sacubitril/valsartan prescription Receives: Other: sacubitril/valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who report a MARS-5 Score of ≥ 80% related to sacubitril/valsartan at the end of the study
Percentage of patients who report a MARS-5 Score of ≥ 80% related to sacubitril/valsartan at the end of the study will be collected.
The MARS-5 questionnaire consists of five questions measuring non-adherence ranging from "never" (5 points) to "always" (1 points), therefore the score has a range from 5 - 25 points. This score will be transformed to a percentage score so that a patient with 5 points ("always" for all answers) scores 100% whereas a patient with 25 points ("never" for all answers) scores 0%.
Measured: Visit 3, up to 30 weeks
Secondary outcomes (8)
Number of patients with pre-defined comorbidities
Number of patients with pre-defined comorbidities will be collected
Measured: Baseline
Number of patients with worsening of HF and reason for event.
Number of patients with worsening of HF and reason for event will be collected
Measured: Up to 30 weeks
Number of deaths
Number of deaths will be collected
Measured: Up to 30 weeks
Number of patients by HF-treatment
Number of patients by HF-treatment (ACEi, ARBs, β-blockers, MRAs, diuretics, SGLT2i) will be collected
Measured: Baseline
Number of patients by reason for initiation of sacubitril/valsartan
Number of patients by reason for initiation of sacubitril/valsartan will be collected
Measured: Baseline
Number of all medications and products that the patient is currently taking on a regular basis
number of all medications and products that the patient is currently taking on a regular basis (including HF medication) will be collected
Measured: Baseline
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ)
It covers physical function, clinical symptoms, social function, self-efficacy and knowledge, each with different Likert scaling wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. The score ranges from 0-100, higher scores mean a better outcome
Measured: Baseline, up to 30 weeks
Change from baseline in weekly patient activity and quality of life (PA & QoL) questionnaire
It consists of seven questions addressing physical activity and the ability to attend patient's normal life (hobbies, house work, appointments etc) within the last week.
Physical activity is documented as time [min] / day of physical activity and time of doing sports [h] /week. Ability of attending normal life is ranged in five categories (I fully agree / I agree / neutral / I don't agree / I don't agree at all).
Measured: Up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start15 May 2023 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Why it stopped: Terminated due to business decision
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870709
- Sponsor's protocol ID
- CLCZ696BDE05
- Acronym
- LOCATE-HF
- Status last verified
- Jul 2023
- First submitted
- 27 Apr 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReaL wOrld, pharmaCy-assessed Adherence to New onseT Entresto® (Sacubitril/Valsartan) in Patients With Chronic Heart Failure - a Prospective Cohort Study (LOCATE-HF)
- ClinicalTrials.gov ID
- NCT05870709
- Acronym / sponsor ID
- LOCATE-HF / CLCZ696BDE05
- Conditions
- Heart Failure
- Keywords
- Heart failure, NIS, Germany, sacubitril, valsartan
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Terminated due to business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 23 May 2023 (actual)
- 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.
This is a multicenter, non-interventional, single arm cohort study with prospective collection of primary data via pharmacists in community pharmacies to describe adherence to sacubitril/valsartan in study patients at the end of the study. Eligible patients with newly prescribed sacubitril/valsartan will be observed in pharmaceutical routine.
Detailed description
The study duration will last up to about 30 weeks per patient and will consist of a approximately three visits - Baseline visit (V1), week 1-12 (V2) and week 13-30 (V3).
No exact date for visit 2 and visit 3 will be enforced, to avoid interference with usual care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sacubitril/valsartan | – | Other: sacubitril/valsartanpatient with a first ambulatory sacubitril/valsartan prescription |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure who pick up their first ambulatory sacubitril/valsartan prescription in approximately 50 participating pharmacies all over Germany.
Key inclusion criteria (4 listed)
- Patients with first ambulatory sacubitril/valsartan prescription at screening
- Internet enabled device / smartphone (patient or affiliate)
- ≥ 18 years of age
- Written informed consent to participate in the study
Key exclusion criteria (3 listed)
- Depression-related medication, depression-related comorbidities (patient-reported)
- Patients with unstable acute complications or with an advanced illness likely to interfere with participation in this trial as judged by the enrolling pharmacist
- Simultaneous participation in any interventional trial or simultaneous participation in another Novartis-sponsored non-interventional study with sacubitril/valsartan
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/valsartanThere is no treatment allocation. Patients with a first ambulatory sacubitril/valsartan prescription who are interested in study participation will be enrolled. | Other | sacubitril/valsartan |
Primary outcome
Percentage of patients who report a MARS-5 Score of ≥ 80% related to sacubitril/valsartan at the end of the study
Time frame: Visit 3, up to 30 weeks
Percentage of patients who report a MARS-5 Score of ≥ 80% related to sacubitril/valsartan at the end of the study will be collected. The MARS-5 questionnaire consists of five questions measuring non-adherence ranging from "never" (5 points) to "always" (1 points), therefore the score has a range from 5 - 25 points. This score will be transformed to a percentage score so that a patient with 5 points ("always" for all answers) scores 100% whereas a patient with 25 points ("never" for all answers) scores 0%.
8 secondary outcomes
Number of patients with pre-defined comorbidities
Time frame: Baseline
Number of patients with worsening of HF and reason for event.
Time frame: Up to 30 weeks
Number of deaths
Time frame: Up to 30 weeks
Number of patients by HF-treatment
Time frame: Baseline
Number of patients by reason for initiation of sacubitril/valsartan
Time frame: Baseline
Number of all medications and products that the patient is currently taking on a regular basis
Time frame: Baseline
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline, up to 30 weeks
Change from baseline in weekly patient activity and quality of life (PA & QoL) questionnaire
Time frame: Up to 30 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Novartis Pharmaceuticals.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Percentage of patients who report a MARS-5 Score of ≥ 80% related to sacubitril/valsartan at the end of the study (time frame: Visit 3, up to 30 weeks). 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 6 Jul 2023.