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

NCT04735354 | Completed

• 1 other identifier: CLCZ696BIN01
• Study Type: observational
• Target: 268
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

heart failure with reduced ejection fraction; HFrEF; India; sacubitril; valsartan; electronic medical records; EMRs; retrospective; RWE

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (9)

• Persistence to sacubitril/valsartan

  Up to 12 months post index date

• Proportion of patient discontinuing sacubitril/valsartan

  month 2, month 4, month 6, month 8 and month 12

• Maximum individual dose reached

  6 months post index date

• Time to first dose up-titration

  6 months post index date

• Time to target dose

  6 months post index date

Study Arms (1)

sacubitril/valsartan

Patients administered sacubitril/valsartan by prescription

Drug: sacubitril/valsartan

Interventions

sacubitril/valsartan DRUG

There was no treatment allocation. Patients administered sacubitril/valsartan by prescription that started before inclusion of the patient into the study were enrolled.

sacubitril/valsartan

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of HF specified as preserved/mid-range ejection fraction

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigational Site

Mumbai, India

Location

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 3, 2021
• Study Start: October 27, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)