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To Study the Dosage pattern and Demographic characteristics in Heart Failure patients initiated with ARNI in India

A Study Assessing the Dosage pattern and Demographic characteristics in Heart Failure reduced Ejection Fraction patients initiated with Angiotensin Receptor Neprilysin Inhibitor in India (ADD ARNI)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/07/071165
Enrollment
3000
Registered
2024-07-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: I509- Heart failure, unspecified

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Cipla Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either gender or aged more than 18 years Patients with documented heart failure with reduced left ventricular ejection fraction less than 40 percent not more than 3 months prior to enrolment Patients with NYHA class II IV and not hospitalized in the past 1 month prior to enrolment ARNi naïve symptomatic, chronic HFrEF patients which includes recently diagnosed patients OR stable chronic HFrEF patients Patients eligible for initiation of ARNi therapy as per the clinical judgement of the treating physician Provide written informed consent

Exclusion criteria

Exclusion criteria: Patients who are deemed ineligible for this study at the discretion of the treating physician Pregnant and Lactating female Patients with acute decompensated heart failure Patients with Hyperkalemia potassium level more than or equal to 5.30 mmol per Litres within the past 2 weeks Patients are currently participating in another clinical study

Design outcomes

Primary

MeasureTime frame
To assess the dosage pattern and treatment persistence with ARNi therapy in HFrEF patients in IndiaTimepoint: Baseline and 12 weeks

Secondary

MeasureTime frame
To describe the medication dosage pattern and the implementation of GDMT in HFrEF patients who are initiated with ARNi To evaluate the safety of ARNi therapy To evaluate the effectiveness of ARNi therapyTimepoint: Baseline and 12 weeks

Countries

India

Contacts

Public ContactDr Nitin Zalte

Cipla Ltd

nitin.zalte@cipla.com9004687211

Outcome results

None listed

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