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Active, Not Recruiting

NCT Number: NCT06759077

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

faculty of pharmacy (girls )ALAzhar university

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin (DAPA)

Drug

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

Primary outcomes

  1. 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

    Time frame: up to 24 weeks

Secondary outcomes

  1. Assess the degree of quality of life by Heart Failure Patient Questionnaire to assess cardiac support in dialysis patients

    Time frame: up to 24 weeks

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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