An observational study in Heart Failure, sponsored by Novartis Pharmaceuticals. Withdrawn. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-07-06.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
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.
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.
5,803 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
Browse Heart Failure studies →Novartis Pharmaceuticals is the lead sponsor of 2,712 studies on the registry; 219 are open to participants now.
Of its 583 completed or terminated interventional studies of FDA-regulated products, 435 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with heart failure who pick up their first ambulatory sacubitril/valsartan prescription in approximately 50 participating pharmacies all over Germany.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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%.
Time frame: Visit 3, up to 30 weeks
Number of patients with pre-defined comorbidities
Number of patients with pre-defined comorbidities will be collected
Time frame: Baseline
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
Time frame: Up to 30 weeks
Number of deaths
Number of deaths will be collected
Time frame: Up to 30 weeks
Number of patients by HF-treatment
Number of patients by HF-treatment (ACEi, ARBs, β-blockers, MRAs, diuretics, SGLT2i) will be collected
Time frame: Baseline
Number of patients by reason for initiation of sacubitril/valsartan
Number of patients by reason for initiation of sacubitril/valsartan will be collected
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: Baseline, up to 30 weeks
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).
Time frame: Up to 30 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2023; primary completion for Oct 2024, 17 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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