Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure
Completed
Conditions studied: Chronic Heart Failure
In brief
This study evaluated changes in healthcare resource utilization (HCRU) and costs of care within 12 months following initiation of sacubitril/valsartan (sac/val) in commercially insured and Medicare Advantage (MA) lives in the U.S among adult patients with heart failure with reduced ejection fraction (HFrEF) (cohort 1) and adult patients with chronic heart failure (CHF) (cohort 2).
Key facts
- Study ID
- NCT05613140
- Run by
- Novartis Pharmaceuticals
- People needed
- 9230
- Starts
- 2021-08-02
- Expected to finish
- 2021-11-05
- Last updated by the study team
- 2022-11-15
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Cohort 1 - Adult HFrEF patients
- Newly initiated sacubitril/valsartan during the cohort identification period;
- Presence of an International Classification of Diseases, Tenth revision (ICD-10) diagnosis code for systolic HF (I50.1x, I50.2x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;
- That are ≥ 18 years old at index date;
- That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;
- That are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of <45 days allowed.
- Cohort 2 - Adult CHF patients
- Newly initiated sacubitril/valsartan during the cohort identification period;
- Presence of ICD-10 diagnosis code for systolic HF or diastolic HF (I50.1x, I50.2x, I50.3x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;
- That are ≥ 18 years old at index date;
- That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;
- That are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of <45 days allowed.
You may not qualify if…
- Patients who died during the post-index period will be excluded.
Where it is running
- Novartis Investigative Site — East Hanover, New Jersey, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.