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Clinical Trial Summary

The objective of this trial is to detect impact of Gliflozin on patients with heart failure due to reurgitant rheumatic valve disease


Clinical Trial Description

- Rheumatic heart disease is a chronic sequel of acute rheumatic fever caused by group A β hemolytic Streptococcal pharyngitis and possibly pyoderma, which mimics molecular heart structures so the immune response leads to carditis and valvular heart damage. Damage to valves cause mitral and/or aortic regurgitation, or in long-standing stenosis. Complications of rheumatic heart disease include heart failure, embolic stroke, endocarditis and atrial fibrillation . - Heart failure (HF) is a progressive syndrome characterised by the inability of the heart to provide adequate blood supply to meet the metabolic demand of different tissues . - The recent ESC/AHA/ACC guidelines of HF set medications as class 1 for the HF therapy as ACE-I/ ARNI/beta-blocker/MRA/ SGLT2 I as they reduced the risk of cardiovascular death and worsening HF in patients with HFrEF , Unless contraindicated or not tolerated. - Empagliflozin is an orally available inhibitor sodium glucose co-transporter 2 receptor (SGLT-2), empagliflozin exerts its effect by preventing sodium and glucose reabsorption from proximal convoluted tubules. This leads to increased urinary sodium and glucose excretion, This is associated with a modest osmotic diuresis, blood pressure lowering effect, improvement in arterial stiffness , and decrease in heart rate. - DAPA-HF trial shows: The primary outcome of cardiovascular death, HF hospitalization, for dapagliflozin vs. placebo, was 16.3% vs 21.2% (p < 0.001). - EMPA-REG OUTCOME trial shows: The primary outcome, cardiovascular death or HF hospitalization, for empagliflozin vs. placebo, was 19.4% vs. 24.7% ( p < 0.001). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06097585
Study type Observational
Source Assiut University
Contact Ahmed Y Dandrawy, Bachelor
Phone +201013086863
Email ahmed_youssef200@yahoo.com
Status Not yet recruiting
Phase
Start date December 1, 2023
Completion date April 1, 2025

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