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A real-world study to assess Sacubitril/valsartan in heart failure with reduced ejection fraction patients in India

Sacubitril/valsartan in heart failure with reduced ejection fraction (HFrEF) patients: a real-world study in India

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/01/030802
Enrollment
600
Registered
2021-01-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I501- Left ventricular failure, unspecified

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Novartis Healthcare Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients >= 18 years with a diagnosis of HFrEF as mentioned in database or heart failure with a recording of LVEF A prescription of sacubitril/valsartan

Exclusion criteria

Exclusion criteria: Diagnosis of HF specified as preserved/mid-range ejection fraction

Design outcomes

Primary

MeasureTime frame
The following will be collated from EMRs to describe patient demographic and clinical characteristics at index date:Gender ,Age, Geographic area(divided into 4 zones- North, South, East and West),Functional Class (NYHA classification) HF etiology, Ventricular function defined by LVEF,Medical History,Laboratory parameters,Hospitalizations due to cardiovascular and non-cardiovascular causes, Concomitant medications classified as- Medications for HF & Medications for non-HF conditionsTimepoint: Index Date

Secondary

MeasureTime frame
Dose titration of sacubitril/valsartan: Assessed for a period of 6 months post index date. Key outcomes will be- Median value of maximum individual dose reached along with other descriptive statistics will be reported. Median time to first dose up-titration along with other descriptive statistics will be reported. Median time to target dose along with other descriptive statistics will be reported Timepoint: 6 months post index date;Persistence to sacubitril/valsartan: Defined as to time duration from initiation to discontinuation of therapy. Persistence up to 12 months post index date will be assessed using Kaplanâ??Meier (KM) methods. Multivariate Cox models will be used to explore potential factors that could contribute to time to discontinuation of therapy. Proportion of patient discontinuing sacubitril/valsartan at 2, 4, 6, 8 and 12 months will be monitored will be reported as frequency (n) and percentage (%). Timepoint: Initiation to Discontinuation of therapy

Countries

India

Contacts

Public ContactDr Shankar Kumar

Novartis Healthcare Private Limited

shankar.kumar@novartis.com9810187232

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026