Heart Failure Clinical Trial
— LOCATE-HFOfficial title:
ReaL wOrld, pharmaCy-assessed Adherence to New onseT Entresto® (Sacubitril/Valsartan) in Patients With Chronic Heart Failure - a Prospective Cohort Study (LOCATE-HF)
NCT number | NCT05870709 |
Other study ID # | CLCZ696BDE05 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | May 15, 2023 |
Est. completion date | October 31, 2024 |
Verified date | July 2023 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: 1. Patients with first ambulatory sacubitril/valsartan prescription at screening 2. Internet enabled device / smartphone (patient or affiliate) 3. = 18 years of age 4. Written informed consent to participate in the study Exclusion Criteria: 1. Depression-related medication, depression-related comorbidities (patient-reported) 2. Patients with unstable acute complications or with an advanced illness likely to interfere with participation in this trial as judged by the enrolling pharmacist 3. Simultaneous participation in any interventional trial or simultaneous participation in another Novartis-sponsored non-interventional study with sacubitril/valsartan |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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%. |
Visit 3, up to 30 weeks | |
Secondary | Number of patients with pre-defined comorbidities | Number of patients with pre-defined comorbidities will be collected | Baseline | |
Secondary | 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 | Up to 30 weeks | |
Secondary | Number of deaths | Number of deaths will be collected | Up to 30 weeks | |
Secondary | Number of patients by HF-treatment | Number of patients by HF-treatment (ACEi, ARBs, ß-blockers, MRAs, diuretics, SGLT2i) will be collected | Baseline | |
Secondary | Number of patients by reason for initiation of sacubitril/valsartan | Number of patients by reason for initiation of sacubitril/valsartan will be collected | Baseline | |
Secondary | 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 | Baseline | |
Secondary | 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 | Baseline, up to 30 weeks | |
Secondary | 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). |
Up to 30 weeks |
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