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

Completed

• Conditions: Heart Failure
• Interventions: Drug: sacubitril/valsartan

• Registration Number: NCT04735354
• Lead Sponsor: Novartis Pharmaceuticals

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.

Study Timeline

• Study Start: 2020-10-27
• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-02-03
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sacubitril/valsartan	sacubitril/valsartan	Patients administered sacubitril/valsartan by prescription

Primary Outcome Measures

Name	Time	Method
Age information	Index date	Age information was reported
Gender information	Index date	Gender information was reported
Number of Hospitalizations	1.5 years	Hospitalizations due to cardiovascular and non-cardiovascular causes
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).
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).
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 participants by Geographic area	idex date	Geographic area divided into 4 zones- North, South, East and West
Body Mass Index	Index date	Median value body mass index was reported
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 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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigational Site; 🇮🇳 Mumbai, India