Improvement in Hearts Condition with different doses of novel Dapagliflozin in patient of Heart Failure and Comparison of strength and side effects in Between Different Doses of Dapagliflozin

Safety and Efficacy Comparison of 5 mg and 10 mg of Dapagliflozin in Patients with Heart Failure with Reduced Ejection Fraction - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080087

Enrollment

Registered

2025-02-07

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: I504- Combined systolic (congestive) anddiastolic (congestive) heart failure

Interventions

Intervention1: 5mg dapagliflozin, orally, once a day: 5mg of dapagliflozin, orally, once a day, after lunch, will be given to patient of heart failure with reduced ejection fraction and followed up an

Eligibility

Inclusion criteria

Inclusion criteria: Eligibility requirements included an age of more than 18 years, an ejection fraction of 40% or less, and New York Heart Association (NYHA) class II, III, or IV symptoms.

Exclusion criteria

Exclusion criteria: unacceptable side effects with dapagliflozin in past, recent treatment with dapagliflozin, Hypotension, eGFR below 30ml/minute

Design outcomes

Primary

Measure	Time frame
1. To compare change in NTproBNP from baseline 2.To compare change in Echocardiographic changes (ejection fraction, left ventricular end diastolic diameter, left ventricular diastolic dysfunction E/E ) from baseline 3.Incidence of adverse eventsTimepoint: 1. To compare change in NTproBNP from baseline at the end of 1 month, 3 month and 6 month. 2.To compare change in Echocardiographic changes (ejection fraction, left ventricular end diastolic diameter, left ventricular diastolic dysfunction E/E ) from baseline at the end of 1 month, 3 month and 6 month. 3.Incidence of adverse events during 6 months.	—

Measure

Time frame

1. To compare change in NTproBNP from baseline 2.To compare change in Echocardiographic changes (ejection fraction, left ventricular end diastolic diameter, left ventricular diastolic dysfunction E/E ) from baseline 3.Incidence of adverse eventsTimepoint: 1. To compare change in NTproBNP from baseline at the end of 1 month, 3 month and 6 month. 2.To compare change in Echocardiographic changes (ejection fraction, left ventricular end diastolic diameter, left ventricular diastolic dysfunction E/E ) from baseline at the end of 1 month, 3 month and 6 month. 3.Incidence of adverse events during 6 months.

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Secondary

Measure	Time frame
The secondary outcomes were the total number of hospitalizations for heart failure (including repeat admissions) & cardiovascular deathsTimepoint: At the end of 6th month.	—

Countries

India

Contacts

Public ContactAla Ram

Dr. S. N. Medical college jodhpur

drrohitmathur@rediffmail.com9462200997

Outcome results

None listed

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