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

NCT05870709 | Withdrawn

• 1 other identifier: CLCZ696BDE05
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Keywords

Heart failure; NIS; Germany; sacubitril; valsartan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of patients with pre-defined comorbidities

  Baseline

• Number of patients with worsening of HF and reason for event.

  Up to 30 weeks

• Number of deaths

  Up to 30 weeks

• Number of patients by HF-treatment

  Baseline

• Number of patients by reason for initiation of sacubitril/valsartan

  Baseline

Study Arms (1)

sacubitril/valsartan

patient with a first ambulatory sacubitril/valsartan prescription

Other: sacubitril/valsartan

Interventions

sacubitril/valsartan OTHER

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

sacubitril/valsartan

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 23, 2023
• Study Start: May 15, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share