Heart Failure With Preserved Ejection Fraction Clinical Trial
Official title:
The Effect of Addition of Metformin to SGLT2 In Diabetic Patients With Heart Failure With Preserved Ejection Fraction
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
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 1, 2024 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 74 Years |
Eligibility | Inclusion Criteria: 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 Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | clinical research uint- El-sheikh zayed specialized hospital SMC- Egyptian Ministry of health | Cairo |
Lead Sponsor | Collaborator |
---|---|
October University for Modern Sciences and Arts | clinical research unit, El-sheikh zayed specialized hospital - Egyptian Ministry of health |
Egypt,
ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S140-S157. doi: 10.2337/dc23-S009. — View Citation
Kittleson MM, Panjrath GS, Amancherla K, Davis LL, Deswal A, Dixon DL, Januzzi JL Jr, Yancy CW. 2023 ACC Expert Consensus Decision Pathway on Management of Heart Failure With Preserved Ejection Fraction: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2023 May 9;81(18):1835-1878. doi: 10.1016/j.jacc.2023.03.393. Epub 2023 Apr 19. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospitalization rate | Hospitalization rate | baseline, 3 and 6 months | |
Primary | HRQOL using Minnesota Living with Heart Failure Questionnaire for quality-of-life evaluation (MLFHQ) | HRQOL using Minnesota Living with Heart Failure Questionnaire for quality-of-life evaluation (MLFHQ) | baseline, 3 and 6 months | |
Secondary | The change in the mean early diastolic mitral annular velocity (mean e'), at 3 and 6 months | The change in the mean early diastolic mitral annular velocity (mean e'), at 3 and 6 months | baseline, 3 and 6 months | |
Secondary | adverse drug effects | adverse drugs effects | baseline, 3 and 6 months | |
Secondary | Change in N-terminal pro-BNP (NT-proBNP) | Change in N-terminal pro-BNP (NT-proBNP) | baseline, 3 and 6 months | |
Secondary | Neutrophil/lymphocyte ratio -AMPK pathway | Neutrophil/lymphocyte ratio
-AMPK pathway |
baseline, 3 and 6 months | |
Secondary | Inflammatory and oxidative stress | Inflammatory and oxidative stress | baseline, 3 and 6 months | |
Secondary | Change in body weight | Change in body weight | baseline, 3 , 6 months |
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