LOCATE-HF: Real World, Pharmacy-assessed Adherence to New Onset Entresto® (Sacubitril/Valsartan) in Patients With Chronic Heart Failure

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05870709

Collaborator

(none)

500

Enrollment

17.6

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: sacubitril/valsartan

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

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Anticipated Study Start Date :

May 15, 2023

Anticipated Primary Completion Date :

Oct 31, 2024

Anticipated Study Completion Date :

Oct 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
sacubitril/valsartan patient with a first ambulatory sacubitril/valsartan prescription	Other: sacubitril/valsartan There is no treatment allocation. Patients with a first ambulatory sacubitril/valsartan prescription who are interested in study participation will be enrolled.

Arm

Intervention/Treatment

sacubitril/valsartan

patient with a first ambulatory sacubitril/valsartan prescription

Other: sacubitril/valsartan

There is no treatment allocation. Patients with a first ambulatory sacubitril/valsartan prescription who are interested in study participation will be enrolled.

Outcome Measures

Primary Outcome Measures

Percentage of patients who report a MARS-5 Score of ≥ 80% related to sacubitril/valsartan at the end of the study [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%.

Secondary Outcome Measures

Number of patients with pre-defined comorbidities [Baseline]
Number of patients with pre-defined comorbidities will be collected
Number of patients with worsening of HF and reason for event. [Up to 30 weeks]
Number of patients with worsening of HF and reason for event will be collected
Number of deaths [Up to 30 weeks]
Number of deaths will be collected
Number of patients by HF-treatment [Baseline]
Number of patients by HF-treatment (ACEi, ARBs, β-blockers, MRAs, diuretics, SGLT2i) will be collected
Number of patients by reason for initiation of sacubitril/valsartan [Baseline]
Number of patients by reason for initiation of sacubitril/valsartan will be collected
Number of all medications and products that the patient is currently taking on a regular basis [Baseline]
number of all medications and products that the patient is currently taking on a regular basis (including HF medication) will be collected
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) [Baseline, up to 30 weeks]
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
Change from baseline in weekly patient activity and quality of life (PA & QoL) questionnaire [Up to 30 weeks]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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