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Dapagliflozin in Heart Failure

Efficacy and Safety of addition of Dapagliflozin to conventional therapy in patients of Heart Failure with Mildly Reduced and Preserved Ejection Fraction: A placebo controlled double blind study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047725
Enrollment
100
Registered
2022-11-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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: Dapagliflozin: SGLT2 inhibitor 10mg daily tablet given for one group Dose 10mg OD morning, oral route, for 6 months Control Intervention1: Placebo: placebo one tablet per day oral rout

Sponsors

Sanjay Kumar R
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients willing singned informed consent 2.Patients with documented diagnosis of HFpEF and HFmrEF with medical history of symptoms and signs of Heart Failure 3.Patients with LVEF 40-60% or evidence of structural Heat disease

Exclusion criteria

Exclusion criteria: 1.Patients who are not willing to sign informed consent. 2.Patients with LVEF 3.Patients with eGFR 4.Patients who are intolerance to Dapagliflozin

Design outcomes

Primary

MeasureTime frame
Efficacy of Dapagliflozin over placebo (blood and eco-cardiogram parameters) when added to standard regimen in HFpEF and HFmrEFTimepoint: At baseline, 6 months—

Secondary

MeasureTime frame
1.Safety and tolerability of Dapagliflozin 3.improvement in patent reported outcomes measured by KCCQ-12(Kansas City Cardiomyopathy Questioner)Timepoint: baseline, 3 months, 6 months—

Countries

India

Contacts

Public ContactSanjay Kumar R

G R Medical College

saroj.kothari@rediffmail.com9827322002

Outcome results

None listed

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