Cardio Protective Effect of SGL2I in Hemodialysis Patients and Its Impact on Patient Quality of Life

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-28

Study Completion Date

2025-12-28

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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standard treatment

Adult patients with advanced CKD who will take the standard treatment for 6months.

Group Type NO_INTERVENTION

No interventions assigned to this group

interventional Group

adult patients with advanced CKD who will take SGL2I(DAPAGLIFLOZINE at a dose (10 mg/day) orally for 6months

Group Type EXPERIMENTAL

Dapagliflozin (DAPA)

Intervention Type DRUG

adult patients with advanced CKD who will take SGL2I(DAPAGLIFLOZINE at a dose (10 mg/day) orally for 6months

Interventions

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Dapagliflozin (DAPA)

adult patients with advanced CKD who will take SGL2I(DAPAGLIFLOZINE at a dose (10 mg/day) orally for 6months

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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suzan.D.zakaria

Pharmacist at Clinical Pharmacy Department, Faculty of Pharmacy (Girls), Al-Azhar University Master Degree of Pharmaceutical Sciences (Clinical Pharmacy), Al-Azhar University (2023)

Responsibility Role PRINCIPAL_INVESTIGATOR