Clinical trial NCT04735354: Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction Patients: a Real World Study in India
Official title: Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction Patients: a Real World Study in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: heart failure with reduced ejection fraction
HFrEF
India
sacubitril
valsartan
electronic medical records
EMRs
retrospective
RWE
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-02-03
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Age information
timeFrame: Index date
measure: Gender information
timeFrame: Index date
measure: Number of participants by Geographic area
timeFrame: idex date
measure: Functional Class (New York Heart Association (NYHA) classification)
timeFrame: index date
measure: Body Mass Index
timeFrame: Index date
measure: Classification of Heart Failure by etiology
timeFrame: 1.5 years
measure: Change in ventricular function defined by Left Ventricular Ejection Fraction (LVEF)
timeFrame: Index date, 1.5 years
measure: Medical History
timeFrame: 1.5 years
measure: Number of participants with notable changes in laboratory parameters
timeFrame: Baseline, 1.5 years
measure: Number of Hospitalizations
timeFrame: 1.5 years
measure: Number of participants with concomitant medications
timeFrame: up to 6 months pre index date, Up to 6 months post index date
measure: Number of patients with other treatments for heart failure
timeFrame: 1.5 years
Secondary outcomes:
measure: Persistence to sacubitril/valsartan
timeFrame: Up to 12 months post index date
measure: Proportion of patient discontinuing sacubitril/valsartan
timeFrame: month 2, month 4, month 6, month 8 and month 12
measure: Maximum individual dose reached
timeFrame: 6 months post index date
measure: Time to first dose up-titration
timeFrame: 6 months post index date
measure: Time to target dose
timeFrame: 6 months post index date
measure: Individual dose
timeFrame: 6 months post index date
measure: Titration patterns
timeFrame: 1.5 years
measure: Proportion of patients being titrated to 100mg from 50mg
timeFrame: 1.5 years
measure: Proportion of patients being titrated to 200mg from 100mg
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Novartis Investigational Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: