Gliflozins on HF in Regurgitant Rheumatic Heart

Assiut University

Status

Not yet enrolling

Conditions

Rheumatic Heart Disease

Heart Failure

Treatments

Drug: SGLT2 inhibitor

Study type

Observational

Funder types

Other

Identifiers

NCT06097585

gliflozins on rheumatic HF

Details and patient eligibility

About

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

Full 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).

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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