Heart Failure
Conditions
Keywords
heart failure with reduced ejection fraction, HFrEF, India, sacubitril, valsartan, electronic medical records, EMRs, retrospective, RWE
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.
Interventions
DRUGsacubitril/valsartan
There was no treatment allocation. Patients administered sacubitril/valsartan by prescription that started before inclusion of the patient into the study were enrolled.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| Classification of Heart Failure by etiology | 1.5 years | Coronary artery disease, valvular, rheumatic heart disease, others, unknown. |
| 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. |
| Body Mass Index | Index date | Median value body mass index was reported |
| Age information | Index date | Age information was reported |
| Gender information | Index date | Gender information was reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| Time to target dose | 6 months post index date | Median time to target dose |
| Individual dose | 6 months post index date | The proportion of patients with a starting dose of 50 mg, 100 mg, 200 mg |
| Titration patterns | 1.5 years | 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. |
| Proportion of patients being titrated to 100mg from 50mg | 1.5 years | Proportion of patients being titrated to 100mg from 50mg |
| Proportion of patients being titrated to 200mg from 100mg | 1.5 years | Proportion of patients being titrated to 200mg from 100mg |
Countries
India
Outcome results
None listed