Clinical trial NCT05870709: Real World, Pharmacy-assessed Adherence to New Onset Entresto® (Sacubitril/Valsartan) in Patients With Chronic Heart Failure
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)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Failure
Keywords: Heart failure
NIS
Germany
sacubitril
valsartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heart failure who pick up their first ambulatory sacubitril/valsartan prescription in approximately 50 participating pharmacies all over Germany.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients who report a MARS-5 Score of ≥ 80% related to sacubitril/valsartan at the end of the study
timeFrame: Visit 3, up to 30 weeks
Secondary outcomes:
measure: Number of patients with pre-defined comorbidities
timeFrame: Baseline
measure: Number of patients with worsening of HF and reason for event.
timeFrame: Up to 30 weeks
measure: Number of deaths
timeFrame: Up to 30 weeks
measure: Number of patients by HF-treatment
timeFrame: Baseline
measure: Number of patients by reason for initiation of sacubitril/valsartan
timeFrame: Baseline
measure: Number of all medications and products that the patient is currently taking on a regular basis
timeFrame: Baseline
measure: Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Baseline, up to 30 weeks
measure: Change from baseline in weekly patient activity and quality of life (PA & QoL) questionnaire
timeFrame: Up to 30 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: