Clinical trial NCT06759077: Cardio Protective Effect of SGL2I in Hemodialysis Patients and Its Impact on Patient Quality of Life
Official title: Potential Beneficial Cardio Protective Effect of SGL2I in Hemodialysis Patients and Its Impact on Patient Quality of Life
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Kidney Diseases
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with CKD stage5 (i.e., eGFR \< 15 mL/min/1.73m2) (Inker et al., 2021)

Exclusion Criteria:

* patients who refuse to sign consent
* Patients with acute heart failure , will exclude patients with known prior ischemic heart diseases or ischemic cardiomyopathy
* Autosomal dominant polycystic kidney disease (ADPKD).
* Type 1 diabetes mellitus
* History of ketoacidosis in the last year.
* Known hypersensitivity to SGLT2 inhibitors.
* Known severe hepatic impairment (Child-Pugh class C)
* Pregnant or breastfeeding females

Primary outcomes:
measure: 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
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Assess the degree of quality of life by Heart Failure Patient Questionnaire to assess cardiac support in dialysis patients
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of pharmacy (girls )ALAzhar university
Study officials:
References:
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citation: 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.
citation: 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.
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