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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04735354
• Other study ID #: CLCZ696BIN01
• Status: Completed
• Start date: October 27, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
India	Novartis Investigational Site	Mumbai

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age information	Age information was reported	Index date
Primary	Gender information	Gender information was reported	Index date
Primary	Number of participants by Geographic area	Geographic area divided into 4 zones- North, South, East and West	idex date
Primary	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
Primary	Body Mass Index	Median value body mass index was reported	Index date
Primary	Classification of Heart Failure by etiology	Coronary artery disease, valvular, rheumatic heart disease, others, unknown.	1.5 years
Primary	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
Primary	Medical History	type 2 diabetes, chronic obstructive pulmonary disease (COPD), anemia, chronic renal disease, atrial fibrillation, stroke, hypertension, myocardial infarction	1.5 years
Primary	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
Primary	Number of Hospitalizations	Hospitalizations due to cardiovascular and non-cardiovascular causes	1.5 years
Primary	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
Primary	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	Persistence to sacubitril/valsartan	Defined as time duration from initiation to discontinuation of therapy.	Up to 12 months post index date
Secondary	Proportion of patient discontinuing sacubitril/valsartan	Reported as frequency (n) and percentage (%).	month 2, month 4, month 6, month 8 and month 12
Secondary	Maximum individual dose reached	Median value of maximum individual dose reached will be reported	6 months post index date
Secondary	Time to first dose up-titration	Median time to first dose up-titration	6 months post index date
Secondary	Time to target dose	Median time to target dose	6 months post index date
Secondary	Individual dose	The proportion of patients with a starting dose of 50 mg, 100 mg, 200 mg	6 months post index date
Secondary	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
Secondary	Proportion of patients being titrated to 100mg from 50mg	Proportion of patients being titrated to 100mg from 50mg	1.5 years
Secondary	Proportion of patients being titrated to 200mg from 100mg	Proportion of patients being titrated to 200mg from 100mg	1.5 years