Gliflozins on HF in Regurgitant Rheumatic Heart

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

Detailed Description
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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).

Official Title
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Effect of Gliflozins on Heart Failure Due to Regurgitant Rheumatic Valve Disease

Conditions
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Rheumatic Heart Disease, Heart Failure

Intervention / Treatment
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* Drug: SGLT2 inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All male or female patients having rheumatic heart disease with either mitral, aortic, tricuspid regurge as a single or combined valvular lesion Patients aged 18 years or older at time of inclusion in the study Patients with HF currently in NYHA class II-IV, or asymptomatic patients with proved mitral regurgitant lesion. Body Mass Index (BMI) < 45 kg/m2 Exclusion Criteria: Advanced stage liver and kidney failure (glomerular filtration rate < 20 mL/min/1.73 m2). Patient with implanted cardiac pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac re-synchronization therapy (CRT) or implanted left ventricular assist device (LVAD) Diagnosis of cardiomyopathy induced by other etiologies rather than rheumatic heart disease eg, ischemia , dilated cardiomyopathy,…..etc within the 12 months prior to Visit 1 Known allergy or hypersensitivity to SGLT-2 inhibitors Women who are pregnant, nursing, or who plan to become pregnant while in the trial ongoing hematological diseases and malignancies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SGLT2I Group<br>the case group that will receive SGLT2I in the treatment | Drug: SGLT2 inhibitor<br>* case control study in which group will receive SGLT2I and group will not , to detect impact of the drug in changing NYHA class for heart failure and echographic parameter<br>* Other names: gliflozins;|
| non - SGLT2I Group<br>the control group that will not receive SGLT2I in the treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the clinical condition | improving or worsening in NYHA class: I- Ordinary physical activity does not cause undue fatigue, dyspnea, or palpitations. II- Ordinary physical activity causes fatigue, dyspnea, palpitations, or angina. III- Comfortable at rest; less than ordinary physical activity causes fatigue, dyspnea, palpitations, or angina. IV- Symptoms occur at rest; any physical activity increases discomfort. | 6 months up to 1 year | 
| change of the function and regurge | improving or worsening in echocardiographic parameter : ejection fraction by simpson methods severity of regurge by color Doppler and continuous wave Doppler | 6 months up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiovascular event | monitor rate for Cardiovascular death, non-fatal stroke, non-fatal myocardial infarction and hospitalization for HF between 2 groups | 6 months up to 1 year | 
| Glomerular filtration rate affection | monitor rate of decline in the estimated glomerular filtration rate between 2 groups | 6 months up to 1 year | 
| urinary tract infection | incidence of urinary tract infection between 2 groups by following urine analysis | 6 months up to 1 year |