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To study the effect of a medication(SGLT 2 inhibitor) on the structural changes in the heart in patients with poor heart pumping and irregular heart rhythm

Effects of SGLT2 inhibitors on cardiac remodelling in patients with atrial fibrillation and left ventricular systolic dysfunction- An observational study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/08/056196
Enrollment
40
Registered
2023-08-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: I482- Chronic atrial fibrillation Health Condition 2: I501- Left ventricular failure, unspecified

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Kasturba Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a)All patients with non-valvular AF with LV systolic dysfunction (LVEF <50%) b)Coronary artery disease (Both revascularized and non-revascularized) with AF and LV systolic dysfunction.

Exclusion criteria

Exclusion criteria: a)Valvular AF b)Severe systemic infection c)Serious liver or renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73 m2) d)Pregnant or breastfeeding, or planning to conceive in the study period (female patients only) e)Dehydration (abnormal hematocrit and blood urea nitrogen, symptoms of dehydration) f)Urinary tract or genital infection g)History of hypersensitivity to the study drug h)History of severe ketosis, diabetic coma or precoma i)Any other contraindication to SGLT2 inhibitor j)ICD or coronary revascularization after enrolment into the study

Design outcomes

Primary

MeasureTime frame
To assess improvement in Left ventricular mass index Left atrial volume index in patients with AF with LV systolic dysfunction on SGLT2 inhibitors at baseline & at three to six months mean follow upTimepoint: To assess improvement in Left ventricular mass index Left atrial volume index in patients with AF with LV systolic dysfunction on SGLT2 inhibitors at baseline & at three to six months mean follow up—

Secondary

MeasureTime frame
Include changes in a)Global longitudinal strain of LV b)Left Ventricular (LV) Ejection fraction by Simpson’s method c)Left ventricular (LV) End Diastolic Volume & dimension d)Left ventricular (LV) End Systolic Volume and dimension) Mitral E/e f)Left ventricular contractility- dp/dtTimepoint: Baseline, Between 3-6 months(Follow-up will be advised as part of routine care)—

Countries

India

Contacts

Public ContactDr Ashwini M V

Manipal Academy of Higher Education

padmakumar69@yahoo.co.in9900921428

Outcome results

None listed

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