Gliflozins on HF in Regurgitant Rheumatic Heart
- Conditions
- Heart FailureRheumatic Heart Disease
- Interventions
- Drug: SGLT2 inhibitor
- Registration Number
- NCT06097585
- Lead Sponsor
- Assiut University
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SGLT2I Group SGLT2 inhibitor the case group that will receive SGLT2I in the treatment
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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