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If this study has a cardio protective effect it will affect the mortality and morbidity of advanced CKD patients and improve their quality of life
Cardiovascular disease is the leading cause of mortality, accounting for >50% of deaths with known causes, while cardiovascular mortality is 9-fold higher in these patients compared with age- and sex-matched individuals in the general population Particularly, heart failure poses a significant challenge in the management of ESKD. It frequently develops after initiation of dialysis and is a prominent mortality risk factor among these patients When CKD patients develop HF, increased sodium and fluid retention, and vascular tension will lead to increased preload of the heart. The increased ventricular wall pressure will lead to release biomarkers like natriuretic peptides (NP). Therefore, biomarkers of myocardial stretch are commonly used in the diagnosis and prognosis evaluation of HF. It is worth noting that the negative predictive value of NP is extremely high (0.94-0.98), while the positive predictive value is slightly lower, (0.44-0.57) for chronic heart failure (CHF) and (0.66-0.67) for acute heart failure (AHF), Commonly used myocardial stretch marker include NT-pro BNP .
NT-pro BNP has the advantage that Accuracy of negative diagnosis is extremely high; The prognostic value is the most powerful, especially in CKD stages 4-5 and dialysis patients Traditional therapies to prevent CVD complications in the general population have shown to be ineffective in Chronic kidney disease (CKD). To address the unmet need, further research is needed to evaluate novel therapeutic strategies to improve cardiovascular outcomes among patients on dialysis .
Over the last several years, Sodium-glucose transporter type 2 (SGLT2) inhibitors have been shown to confer substantial kidney and cardiovascular benefits among patients with type 2 diabetes, heart failure, and/or high-risk CKD .
Secondary analyses from these landmark trials demonstrated consistent benefits of SGLT2 inhibitors across many subgroups, supporting the widespread use and incorporation in clinical practice guidelines of this new kidney and cardio protective drug class.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard treatment | No Intervention | Adult patients with advanced CKD who will take the standard treatment for 6months. | |
| interventional Group | Experimental | adult patients with advanced CKD who will take SGL2I(DAPAGLIFLOZINE at a dose (10 mg/day) orally for 6months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin (DAPA) | Drug | adult patients with advanced CKD who will take SGL2I(DAPAGLIFLOZINE at a dose (10 mg/day) orally for 6months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the cardio protective effect of SGL2 inhibitors(DAPAGLIFLOZINE (10 mg/day)) in dialysis patients ,by measuring human N terminal pro brain natriuretic peptide (N -pro BNB) at baseline and after 6months | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the degree of quality of life by Heart Failure Patient Questionnaire to assess cardiac support in dialysis patients | up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of pharmacy (girls )ALAzhar university | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36814454 | Background | Kobo O, Abramov D, Davies S, Ahmed SB, Sun LY, Mieres JH, Parwani P, Siudak Z, Van Spall HGC, Mamas MA. CKD-Associated Cardiovascular Mortality in the United States: Temporal Trends From 1999 to 2020. Kidney Med. 2022 Dec 28;5(3):100597. doi: 10.1016/j.xkme.2022.100597. eCollection 2023 Mar. | |
| 38916852 | Background |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Rashid AM, Jamil A, Khan Z, Shakoor M, Kamal UH, Khan II, Akram A, Shahabi M, Yamani N, Ali S, Fatima K, Kamdi A, Junaid M, Khan AM, Mattumpuram J, Perswani P. Trends in mortality related to kidney failure and diabetes mellitus in the United States: a 1999-2020 analysis. J Nephrol. 2024 Sep;37(7):1833-1841. doi: 10.1007/s40620-024-01990-z. Epub 2024 Jun 25. |
| 34447992 | Background | McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available. |
| 32710942 | Background | Han X, Zhang S, Chen Z, Adhikari BK, Zhang Y, Zhang J, Sun J, Wang Y. Cardiac biomarkers of heart failure in chronic kidney disease. Clin Chim Acta. 2020 Nov;510:298-310. doi: 10.1016/j.cca.2020.07.040. Epub 2020 Jul 23. |
| 38913113 | Background | Siddiqui R, Obi Y, Dossabhoy NR, Shafi T. Is There a Role for SGLT2 Inhibitors in Patients with End-Stage Kidney Disease? Curr Hypertens Rep. 2024 Dec;26(12):463-474. doi: 10.1007/s11906-024-01314-3. Epub 2024 Jun 24. |
| 33031522 | Background | McGuire DK, Shih WJ, Cosentino F, Charbonnel B, Cherney DZI, Dagogo-Jack S, Pratley R, Greenberg M, Wang S, Huyck S, Gantz I, Terra SG, Masiukiewicz U, Cannon CP. Association of SGLT2 Inhibitors With Cardiovascular and Kidney Outcomes in Patients With Type 2 Diabetes: A Meta-analysis. JAMA Cardiol. 2021 Feb 1;6(2):148-158. doi: 10.1001/jamacardio.2020.4511. |
| 36272764 | Background | Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease. Kidney Int. 2022 Nov;102(5S):S1-S127. doi: 10.1016/j.kint.2022.06.008. No abstract available. |
| D052801 | Male Urogenital Diseases |