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The Safety of Dapagliflozin in Hemodialysis Patients With Heart Failure

NCT05141552 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-05-10

No results posted yet for this study

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-.

Conditions

  • Hemodialysis Complication

Interventions

DRUG

Dapagliflozin 10Mg Tab

In both group, subjects keep blood purification and anti heart failure treatment, including ARNI, RASi, Aldosterone inhibitors and beta receptor blocker.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Leyi Gu · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-03
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05141552 on ClinicalTrials.gov