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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 1, 2022

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • sacubitril/valsartan
    • Patients administered sacubitril/valsartan by prescription

Clinical Trial Outcome Measures

Primary Measures

  • Age information
    • Time Frame: Index date
    • Age information will be reported
  • Gender information
    • Time Frame: Index date
    • Gender information will be reported
  • Number of participants by Geographic area
    • Time Frame: idex date
    • Geographic area divided into 4 zones- North, South, East and West
  • 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.
  • Body Mass Index
    • Time Frame: Index date
    • Median value body mass index will be reported
  • Classification of Heart Failure by etiology
    • Time Frame: 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)
    • 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).
  • 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 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 Hospitalizations
    • Time Frame: 1.5 years
    • Hospitalizations due to cardiovascular and non-cardiovascular causes
  • 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.
  • 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).

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.