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

Heart Failure Clinical Trial

— LOCATE-HF  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05870709
• Other study ID #: CLCZ696BDE05
• Status: Withdrawn
• Start date: May 15, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: July 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Eligible patients with newly prescribed sacubitril/valsartan will be observed in pharmaceutical routine.

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.

Recruitment information / eligibility

• Status: Withdrawn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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

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