Clinical Trial Details
| Trial ID: | L4672 |
| Source ID: | NCT06080802 |
| Associated Drug: | Metformin |
| Title: | The Effect of Addition of Metformin to SGLT2 In Diabetic Patients With Heart Failure With Preserved Ejection Fraction |
| Acronym: | |
| Status: | NOT_YET_RECRUITING |
| Study Results: | NO |
| Results: | |
| Conditions: | Heart Failure With Preserved Ejection Fraction|Diabete Type 2 |
| Interventions: | DRUG: Metformin |
| Outcome Measures: | Primary: Hospitalization rate, Hospitalization rate, baseline, 3 and 6 months|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|adverse drug effects, adverse drugs effects, baseline, 3 and 6 months|Change in N-terminal pro-BNP (NT-proBNP), Change in N-terminal pro-BNP (NT-proBNP), baseline, 3 and 6 months|Neutrophil/lymphocyte ratio -AMPK pathway, Neutrophil/lymphocyte ratio -AMPK pathway, baseline, 3 and 6 months|Inflammatory and oxidative stress, Inflammatory and oxidative stress, baseline, 3 and 6 months|Change in body weight, Change in body weight, baseline, 3 , 6 months |
| Sponsor/Collaborators: | Sponsor: October University for Modern Sciences and Arts | Collaborators: clinical research unit, El-sheikh zayed specialized hospital - Egyptian Ministry of health |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2|PHASE3 |
| Enrollment: | 80 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2023-11-01 |
| Completion Date: | 2024-12-01 |
| Results First Posted: | |
| Last Update Posted: | 2023-10-12 |
| Locations: | clinical research uint- El-sheikh zayed specialized hospital SMC- Egyptian Ministry of health, Cairo, Egypt |
| URL: | https://clinicaltrials.gov/show/NCT06080802 |
