Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction Patients: a Real World Study in India

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction Patients: a Real World Study in India

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: sacubitril/valsartan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sacubitril/valsartan<br>Patients administered sacubitril/valsartan by prescription | Drug: sacubitril/valsartan<br>* There was no treatment allocation. Patients administered sacubitril/valsartan by prescription that started before inclusion of the patient into the study were enrolled.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age information | Age information was reported | Index date | 
| Gender information | Gender information was reported | Index date | 
| Number of participants by Geographic area | Geographic area divided into 4 zones- North, South, East and West | idex date | 
| Functional Class (New York Heart Association (NYHA) classification) | 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. | index date | 
| Body Mass Index | Median value body mass index was reported | Index date | 
| Classification of Heart Failure by etiology | Coronary artery disease, valvular, rheumatic heart disease, others, unknown. | 1.5 years | 
| Change in ventricular function defined by Left Ventricular Ejection Fraction (LVEF) | An ejection fraction (EF) is the volumetric fraction (or portion of the total) of fluid ejected from a chamber with each contraction (or heartbeat). | Index date, 1.5 years | 
| Medical History | type 2 diabetes, chronic obstructive pulmonary disease (COPD), anemia, chronic renal disease, atrial fibrillation, stroke, hypertension, myocardial infarction | 1.5 years | 
| Number of participants with notable changes in laboratory parameters | Safety measured by the notable post-baseline changes in laboratory parameters compared to baseline | Baseline, 1.5 years | 
| Number of Hospitalizations | Hospitalizations due to cardiovascular and non-cardiovascular causes | 1.5 years | 
| Number of participants with concomitant medications | 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. | up to 6 months pre index date, Up to 6 months post index date | 
| Number of patients with other treatments for heart failure | Other treatments for heart failure like implantable cardioverter-defibrillator (ICD), and cardiac resynchronization therapy (CRT). | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence to sacubitril/valsartan | Defined as time duration from initiation to discontinuation of therapy. | Up to 12 months post index date | 
| Proportion of patient discontinuing sacubitril/valsartan | Reported as frequency (n) and percentage (%). | month 2, month 4, month 6, month 8 and month 12 | 
| Maximum individual dose reached | Median value of maximum individual dose reached will be reported | 6 months post index date | 
| Time to first dose up-titration | Median time to first dose up-titration | 6 months post index date | 
| Time to target dose | Median time to target dose | 6 months post index date | 
| Individual dose | The proportion of patients with a starting dose of 50 mg, 100 mg, 200 mg | 6 months post index date | 
| Titration patterns | Listings 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. | 1.5 years | 
| Proportion of patients being titrated to 100mg from 50mg | Proportion of patients being titrated to 100mg from 50mg | 1.5 years | 
| Proportion of patients being titrated to 200mg from 100mg | Proportion of patients being titrated to 200mg from 100mg | 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure with reduced ejection fraction, HFrEF, India, sacubitril, valsartan, electronic medical records, EMRs, retrospective, RWE