NCT05141552

The Safety of Dapagliflozin in Hemodialysis Patients With Heart Failure

Name: Clinical Trial NCT05141552
Creator: RenJi Hospital
Keywords: Hemodialysis Complication, Dapagliflozin 10Mg Tab, drug, clinical trial, China

RenJi Hospital·ClinicalTrials.gov·drugRecruiting

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Study focus

Disease/Condition: Hemodialysis Complication
Drug/Device/Intervention: Dapagliflozin 10Mg Tab
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: RenJi Hospital
Location: Shanghai, China

Timeline & enrollment

Phase: N/A
Start date: Jan 03, 2022
End date: Jul 31, 2022
Enrollment: 20 participants

Primary outcome

the number of patients with hypoglycemia or urinary tract infection

Summary

SGLT2 inhibitor is a new type of sugar-lowering medicine and is recommended to treat heart failure. eGFR lower than 30ml/min/1.73M2 is contraindication of SGLT2 inhibitor. Heart failure is one of the most frequency CVD events for hemodialysis patients. But hemodialysis patient is unable to be treated with SGLT2 inhibitors as the contraindication. However, solute and fluid clearance are dependent on dialysis, but not renal function in hemodialysis patients. There is no data of SGLT2 inhibitor on hemodialysis patients. The aim of the present study is evaluate the safety of Dapagliflozin in hemodialysis patients with heart failure.  This is a randomized, control, open study. 20 hemodialysis patients with heart failure will be recruited. 10 of 20 subjects will be treated with dapagliflozin 10mg everyday for 12 weeks. The primary outcome is the number of patients with hypoglycemia or urinary infection. The secondary outcomes is the changes of NT-.

ICD-10 classifications

Kidney dialysisOther dialysisCare involving dialysisMechanical complication of vascular dialysis catheterHaemoglobinuria due to haemolysis from other external causes

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05141552
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05141552 through Pure Global AI's free database. This phase not specified trial is sponsored by RenJi Hospital and is currently Recruiting. The study focuses on Hemodialysis Complication. Target enrollment is 20 participants.

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