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A study to compare the effects of SGLT2 inhibitor medicine alone and in combination with diuretics on heart and kidney health in diabetic and non-diabetic patients with heart failure.

Comparison of SGLT2 inhibitor monotherapy and combination therapy with Loop Diuretics in Heart Failure among diabetic and non-diabetic individuals - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/10/096013
Enrollment
300
Registered
2025-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Sponsors

Kasturba Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged eighteen years and above Diagnosed with heart failure either reduced or preserved ejection fraction (ICD code I50.0 to I50.9) Prescribed either SGLT2 inhibitor monotherapy or combination therapy with SGLT2 inhibitor and loop diuretic Includes both diabetic and non diabetic individuals (ICD code E11.0 to E11.9) Availability of complete clinical records including medication history, laboratory investigations and outcome data Patients managed in either inpatient or outpatient settings

Exclusion criteria

Exclusion criteria: Pregnant women and lactating women Patients with incomplete or missing data Patients with end stage renal disease or those on dialysis Patients receiving SGLT2 inhibitors exclusively for glycemic control without a documented diagnosis of heart failure Patients with chronic illnesses such as malignancy, human immunodeficiency virus infection, nutritional deficiency disorders or gestational diabetes

Design outcomes

Primary

MeasureTime frame
To compare the impact on clinical outcomes, renal function, and cardiac biomarkers between SGLT2 inhibitor monotherapy and combination therapy with loop diuretics in heart failure patients.Timepoint: At Baseline, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline, 52 weeks after baseline, 104 weeks after baseline—

Secondary

MeasureTime frame
To perform subgroup analyses to determine if the observed differences in clinical outcomes, renal function, & cardiac biomarkers vary between diabetic & non-diabetic heart failure patients receiving SGLT2 inhibitor monotherapy versus combination therapy with loop diuretics.Timepoint: At Baseline, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline, 52 weeks after baseline, 104 weeks after baseline—

Countries

India

Contacts

Public ContactDisha Shetty

Manipal College of Pharmaceutical Sciences

prasanna.shetty@manipal.edu9886725129

Outcome results

None listed

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