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A study to understand Effectiveness and safety of CIDMUS tablets in Heart Failure with reduced and Mid-range ejection fraction patients

A prospective, observational, multicenter Real-World Evidence study to assess the effectiveness & safety of CIDMUS (sacubitril - valsartan) in Heart Failure with reduced Ejection Fraction (HFrEF) and Heart Failure with mid-range ejection fraction (HFmrEF) patients in India. - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/03/064528
Enrollment
200
Registered
2024-03-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: I502- Systolic (congestive) heart failure

Interventions

Intervention1: NIL: NIL

Sponsors

Dr. Reddy’s Laboratories Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female patients of Age greater or equal to 18 years 2.Patients diagnosed with Heart Failure with Ejection fraction lessthan 50% at baseline, who were prescribed CIDMUS for the first time or within one week. 3.Patients willing to provide consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Contraindications to the study drug as per physician’s discretion.

Design outcomes

Primary

MeasureTime frame
Change in Ejection Fraction from baseline visit to follow-up visits 1,3,6, and 12 months in Heart failure patients on CIDMUS as per below sub groupsTimepoint: 1,3,6 and 12 months

Secondary

MeasureTime frame
1. Safety assessment - Frequency and severity of AEs 2.Emergency visits due to HF requiring inotropic agents/iv diuretics at 1, 3,6, and 12 months 3.Incidence of hospitalization in HFrEF and HFmrEF patients on CIDMUS at 1,3,6, and 12 months 4.Incidence of cardiac death in HFrEF and HFmrEF patients on CIDMUS at 1,3,6, and 12 months 5.Change in NT-proBNP from baseline visit to follow-up visits 1,3,6, and 12 months in HFrEF and HFmrEF patients on CIDMUS 6. Change in NYHA class from baseline to 1,3,6, and 12 months in HFrEF and HFmrEF patients on CIDMUS 7.Average dose of the drug prescribed & compliance to therapyTimepoint: 1,3,6, and 12 months

Countries

India

Contacts

Public ContactDr Sagar Katare

Dr. Reddy’s Laboratories Limited

sagarkatare@drreddys.com9223772427

Outcome results

None listed

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