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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: sacubitril/valsartan

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.

• Study Type: Observational
• Enrollment (Actual): 268

Contacts and Locations

Study Locations

• India
  • Mumbai, India
    • Novartis Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients ≥18 years with a diagnosis of HFrEF as mentioned in database or heart failure with a recording of LVEF <40% at index date with a prescription of sacubitril/valsartan

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
sacubitril/valsartan; Patients administered sacubitril/valsartan by prescription	Drug: sacubitril/valsartan; There was no treatment allocation. Patients administered sacubitril/valsartan by prescription that started before inclusion of the patient into the study were enrolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Age information	Age information was reported	Index date
Gender information	Gender information was reported	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

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
Maximum individual dose reached	Median value of maximum individual dose reached will be reported	6 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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: India; HFrEF; valsartan; retrospective; RWE; heart failure with reduced ejection fraction; electronic medical records; sacubitril; EMRs
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan; Sacubitril and valsartan sodium hydrate drug combination
• Other Study ID Numbers: CLCZ696BIN01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No