Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction Patients: a Real World Study in India
Study Details
Study Description
Brief Summary
This will be a non-interventional, retrospective EMR analysis of longitudinal prescriptions in India for a period of 1.5 years. Demographic profile of patients with heart failure with reduced ejection fraction on sacubitril/valsartan will be recorded.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
Index date will be date of 1st prescription of sacubitril/valsartan. Dose titration of sacubitril/valsartan will be assessed for a period of 6 months post index date.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| sacubitril/valsartan Patients administered sacubitril/valsartan by prescription |
Drug: sacubitril/valsartan
There is no treatment allocation. Patients administered sacubitril/valsartan by prescription that have started before inclusion of the patient into the study will be enrolled.
|
Outcome Measures
Primary Outcome Measures
- Age information [Index date]
Age information will be reported
- Gender information [Index date]
Gender information will be reported
- Number of participants by Geographic area [idex date]
Geographic area divided into 4 zones- North, South, East and West
- Functional Class (New York Heart Association (NYHA) classification) [index date]
The New York Heart Association Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.
- Body Mass Index [Index date]
Median value body mass index will be reported
- Classification of Heart Failure by etiology [1.5 years]
Coronary artery disease, valvular, rheumatic heart disease, others, unknown. It will also be divided into ischemic and non- ischemic etiology
- Change in ventricular function defined by Left Ventricular Ejection Fraction (LVEF) [Index date, 1.5 years]
An ejection fraction (EF) is the volumetric fraction (or portion of the total) of fluid ejected from a chamber with each contraction (or heartbeat).
- Medical History [1.5 years]
type 2 diabetes, chronic obstructive pulmonary disease (COPD), anemia, chronic renal disease, atrial fibrillation, stroke, hypertension, myocardial infarction
- Number of participants with notable changes in laboratory parameters [Baseline, 1.5 years]
Safety measured by the notable post-baseline changes in laboratory parameters compared to baseline
- Number of Hospitalizations [1.5 years]
Hospitalizations due to cardiovascular and non-cardiovascular causes
- Number of participants with concomitant medications [up to 6 months pre index date, Up to 6 months post index date]
Concomitant medications classified as- Medications for HF: Diuretics, digitalis, beta-Blockers, ACEi, ARBs, MRA, ivabradine, SGLT2 inhibitors. Medications for non-HF conditions: Anti-diabetic medications other than SGLT2 inhibitors (oral and injectable), statin, antiplatelet therapy, oral anti-coagulants.
- Number of patients with other treatments for heart failure [1.5 years]
Other treatments for heart failure like implantable cardioverter-defibrillator (ICD), and cardiac resynchronization therapy (CRT).
Secondary Outcome Measures
- Persistence to sacubitril/valsartan [Up to 12 months post index date]
Defined as time duration from initiation to discontinuation of therapy.
- Proportion of patient discontinuing sacubitril/valsartan [month 2, month 4, month 6, month 8 and month 12]
It will be reported as frequency (n) and percentage (%).
- Maximum individual dose reached [6 months post index date]
Median value of maximum individual dose reached will be reported
- Time to first dose up-titration [6 months post index date]
Median time to first dose up-titration will be reported
- Time to target dose [6 months post index date]
Median time to target dose will be reported
- Individual dose [6 months post index date]
The proportion of patients with a starting dose of 50 mg, 100 mg, 200 mg will be reported
- Titration patterns [1.5 years]
Listings will be provided for all titration patterns which evaluated longitudinally at the patient level as follows: Up-titration' corresponds to all patients who experience an initial increase in sacubitril/valsartan dose post-index, 'Stable up-titration' corresponds to up-titrated patients who experience no subsequent decrease in sacubitril/valsartan dose 'Down-titration' corresponds to all patients who experience an initial dose decrease in sacubitril/valsartan dose post-index, and 'Stable down-titration' corresponds to the proportion of down-titrated patients who experience no subsequent up-titration.
- Proportion of patients being titrated to 100mg from 50mg [1.5 years]
Proportion of patients being titrated to 100mg from 50mg will be reported
- Proportion of patients being titrated to 200mg from 100mg [1.5 years]
Proportion of patients being titrated to 200mg from 100mg will be reported
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients ≥18 years with a diagnosis of HFrEF as mentioned in database or heart failure with a recording of LVEF <40% at or before the index date
-
A prescription of sacubitril/valsartan
Exclusion Criteria:
- Diagnosis of HF specified as preserved/mid-range ejection fraction
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigational Site | Mumbai | India |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLCZ696BIN01