Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction Patients: a Real World Study in India
Overview
- Phase
- Not Applicable
- Intervention
- sacubitril/valsartan
- Conditions
- Heart Failure
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 268
- Locations
- 1
- Primary Endpoint
- Age information
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This was 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 was recorded.
Detailed Description
Index date was date of 1st prescription of sacubitril/valsartan. Dose titration of sacubitril/valsartan was assessed for a period of 6 months post index date.
Investigators
Eligibility 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
Arms & Interventions
sacubitril/valsartan
Patients administered sacubitril/valsartan by prescription
Intervention: sacubitril/valsartan
Outcomes
Primary Outcomes
Age information
Time Frame: Index date
Age information was reported
Gender information
Time Frame: Index date
Gender information was reported
Number of Hospitalizations
Time Frame: 1.5 years
Hospitalizations due to cardiovascular and non-cardiovascular causes
Number of patients with other treatments for heart failure
Time Frame: 1.5 years
Other treatments for heart failure like implantable cardioverter-defibrillator (ICD), and cardiac resynchronization therapy (CRT).
Functional Class (New York Heart Association (NYHA) classification)
Time Frame: 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.
Classification of Heart Failure by etiology
Time Frame: 1.5 years
Coronary artery disease, valvular, rheumatic heart disease, others, unknown.
Change in ventricular function defined by Left Ventricular Ejection Fraction (LVEF)
Time Frame: 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).
Number of participants with notable changes in laboratory parameters
Time Frame: Baseline, 1.5 years
Safety measured by the notable post-baseline changes in laboratory parameters compared to baseline
Number of participants by Geographic area
Time Frame: idex date
Geographic area divided into 4 zones- North, South, East and West
Body Mass Index
Time Frame: Index date
Median value body mass index was reported
Medical History
Time Frame: 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 concomitant medications
Time Frame: 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.
Secondary Outcomes
- Persistence to sacubitril/valsartan(Up to 12 months post index date)
- Proportion of patient discontinuing sacubitril/valsartan(month 2, month 4, month 6, month 8 and month 12)
- Maximum individual dose reached(6 months post index date)
- Time to target dose(6 months post index date)
- Time to first dose up-titration(6 months post index date)
- Individual dose(6 months post index date)
- Titration patterns(1.5 years)
- Proportion of patients being titrated to 100mg from 50mg(1.5 years)
- Proportion of patients being titrated to 200mg from 100mg(1.5 years)