Status:
UNKNOWN
The Effect of Addition of Metformin to SGLT2 In Diabetic Patients With Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
October University for Modern Sciences and Arts
Collaborating Sponsors:
clinical research unit, El-sheikh zayed specialized hospital - Egyptian Ministry of health
Conditions:
Heart Failure With Preserved Ejection Fraction
Diabete Type 2
Eligibility:
All Genders
40-74 years
Phase:
PHASE2
PHASE3
Brief Summary
a prospective open-label, randomized controlled study to evaluate the efficacy of the addition of metformin to SGLT2 in diabetic patient with preserved ejection fraction
Detailed Description
Regardless of the benefits noted with SGLT2is, metformin is recommended as first-line therapy for glycemic control in individuals with T2DM and HF, including HFpEF, with estimated glomerular filtratio...
Eligibility Criteria
Inclusion
- Age of 40 years to 74 years. HFpEF (≥ 50%) Written informed consent of the subject to participate in the study. New York Heart Association functional class I-IV. Diabetic patients SGL-2 naive. Newly diagnosed heart failure of preserved ejection fraction
Exclusion
- Patients with heart failure with reduced ejection fraction (\< 40%) Age less than 40 and more than 74 GFR \< 30 mL/min A1c \> 9 Known allergy to metformin End- stage liver disease Cancer Pregnancy or lactation
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06080802
Start Date
November 1 2023
End Date
December 1 2024
Last Update
October 12 2023
Active Locations (1)
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1
clinical research uint- El-sheikh zayed specialized hospital SMC- Egyptian Ministry of health
Cairo, Egypt