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" TO STUDY HOW SGLT2 INHIBITOR DRUGS IMPROVE HEARTS PUMPING CAPACITY IN NON DIABETIC HEART FAILURE PATIENTS"

Effects of SGLT2 Inhibitors on Left ventricular dimensions and function in non-diabetic patients with heart failure reduced ejection fraction due to non-ischemic and ischemic cardiomyopathy in non-acute coronary syndrome setting

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/02/050151
Enrollment
116
Registered
2023-02-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: I420- Dilated cardiomyopathy

Interventions

Intervention1: Nil: Nil Intervention2: nil: nil

Sponsors

Dr Nagpal Raghav Radhakrishan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: LVEF equal to or less than 45% More than 3 months from ACS event Ischemic Cardiomyopathy patients who have undergone complete revascularization in the form of percutaneous coronary intervention or surgery more than 3 months prior to inclusion in the study Creatinine clearance of less than equal to 30 ml per min per m2 Patients on optimal heart failure therapy, beta blockers ARB ACE inhibitors aldosterone antagonists and or diuretics if tolerated

Exclusion criteria

Exclusion criteria: 1) Diabetes Mellitus 2) Recent ACS, 3) Ischemic cardiomyopathy patients who have not undergone complete revascularization 4) Coronary Revascularization ( percutaneous coronary revascularization or coronary artery bypass grafting) or valvular repair/replacement within 3 months prior to enrolment 5)severe infection 6) serious liver or renal functional failure eGFR 7) alcohol dependency or use of illicit drugs 8) pregnant or breastfeeding, possibly pregnant or planning to become pregnant in the study period (female patients only) 9) urinary tract or genital infection 10) history of hypersensitivity to the study drugs 11) severe ketosis, diabetic coma or precoma 12) ongoing or past history of pancreatitis 13) heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease 14) symptomatic bradycardia or second or third degree heart block without a pacemaker

Design outcomes

Primary

MeasureTime frame
The change in E/e prime ratio between early mitral inflow velocity and mitral annular early diastolic velocity , from baseline to mean of 3-6 months follow upTimepoint: 0, 3-6 months

Secondary

MeasureTime frame
Area length ejection fractionTimepoint: 0, 3-6 months;left atrial volume and indexTimepoint: 0, 3-6 months;Left ventricular ejection fractionTimepoint: 0, 3-6 months;left ventricular end diastolic volume and indexTimepoint: 0, 3-6 months;left ventricular end systolic volume and indexTimepoint: 0, 3-6 months;LV contractility dp/dtTimepoint: 0, 3-6 months;LV mass indexTimepoint: 0, 3-6 months

Countries

India

Contacts

Public ContactDr Raghav Nagpal

KMC Manipal

srao88123@gmail.com8828265971

Outcome results

None listed

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