Heart Failure, Rheumatic Heart Disease
Conditions
Brief summary
The objective of this trial is to detect impact of Gliflozin on patients with heart failure due to reurgitant rheumatic valve disease
Detailed 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).
Interventions
DRUGSGLT2 inhibitor
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
Sponsors
Assiut University
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the clinical condition | 6 months up to 1 year | 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. |
| change of the function and regurge | 6 months up to 1 year | improving or worsening in echocardiographic parameter : * ejection fraction by simpson methods * severity of regurge by color Doppler and continuous wave Doppler |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| major adverse cardiovascular event | 6 months up to 1 year | monitor rate for Cardiovascular death, non-fatal stroke, non-fatal myocardial infarction and hospitalization for HF between 2 groups |
| Glomerular filtration rate affection | 6 months up to 1 year | monitor rate of decline in the estimated glomerular filtration rate between 2 groups |
| urinary tract infection | 6 months up to 1 year | incidence of urinary tract infection between 2 groups by following urine analysis |
Contacts
Primary ContactAhmed Y Dandrawy, Bachelor
Outcome results
None listed