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
- Conditions
- Health Condition 1: I482- Chronic atrial fibrillationHealth Condition 2: I501- Left ventricular failure, unspecified
- Registration Number
- CTRI/2023/08/056196
- Lead Sponsor
- Kasturba Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess improvement in <br/ ><br>Left ventricular mass index <br/ ><br>Left atrial volume index <br/ ><br>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 <br/ ><br>Left ventricular mass index <br/ ><br>Left atrial volume index <br/ ><br>in patients with AF with LV systolic dysfunction on SGLT2 inhibitors at baseline & at three to six months mean follow up
- Secondary Outcome Measures
Name Time Method Include changes in a)Global longitudinal strain of LV b)Left Ventricular (LV) Ejection fraction by Simpsonâ??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)