Clinical trial

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

Name
gliflozins on rheumatic HF
Description
The objective of this trial is to detect impact of Gliflozin on patients with heart failure due to reurgitant rheumatic valve disease
Trial arms
Trial start
2023-12-01
Estimated PCD
2024-12-01
Trial end
2025-04-01
Status
Not yet recruiting
Treatment
SGLT2 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
Arms:
SGLT2I Group
Other names:
gliflozins
Size
150
Primary endpoint
Change of the clinical condition
6 months up to 1 year
change of the function and regurge
6 months up to 1 year
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2023-10-30

1 organization

1 product

2 indications

Organization
Assiut University