Gliflozins on HF in Regurgitant Rheumatic Heart

Launched by ASSIUT UNIVERSITY · Oct 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Gliflozin on patients who have heart failure due to a heart condition known as rheumatic heart disease. Specifically, it focuses on patients who experience problems with their heart valves, which can cause blood to flow backward in the heart. The goal is to see if Gliflozin can help improve their heart function and overall health.

To participate in this trial, individuals must be at least 18 years old and have been diagnosed with rheumatic heart disease involving issues like mitral or aortic valve regurgitation. Eligible participants should be experiencing heart failure symptoms that fall into categories II to IV on a specific scale or have mild symptoms but still show a heart valve issue. However, those with severe liver or kidney failure, certain heart devices, or other specific medical conditions cannot join. If you choose to participate, you will be closely monitored throughout the trial to assess how well the medication works for your condition.

Gender

ALL

Eligibility criteria

• 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