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Clinical Trial Details — Status: Withdrawn

Administrative data

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Status Withdrawn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

Study information

Verified date July 2023
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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