The Safety of Dapagliflozin in Hemodialysis Patients With Heart Failure

• Status: Not yet recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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 a composite of numbers of hypoglycemia events, urinary infection events and abnormal of laboratory results. The secondary outcomes is the changes of NT-.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

1. Understand the present studyAgree and sign informed consert

2. Age is between 18 and 70 Men or women ≧18 years and <70 years of age at screening

3. Treated with maintenance blood purification 2 or 3 times blood purification treatments (including hemodialysis, hemofiltration, hemoperfusion) every week2 or 3 times a week,

4. Blood purification treatment more than 3 month before randomization

5. Blood purification by uUsing AV fistula or artificial vascular access

6. DiagnosisWith chronic heart failure (NYHC II-IV), and NT-proBNP>11500 or BNP>500

7. ARNI or RAS inhibitor or Aldosterone inhibitors or beta receptor blocker treatment for at least 4 weeks with a stable dose.

Exclusion Criteria:

1. Blood purification less than 3 month

2. With fluid overload and URR<50%

3. Have severe hypoglycemia (more than 2 events with 4 weeks prior to sign concert information)

4. Have severe hypotension (blood pressure <90/60mmHg more than 3 times with 4 weeks prior to sign concert information)

5. Have acute pulmonary edema

6. Have ketoacidosis

7. Have active pyelnephritis and symptomatic lower urinary infection

8. Subject is pregnant , is breast feeding

9. Subject has known SGLT2 inhibitor allergy or intolerance adverse reactions

10. Subject is currentluy enrolled in or has not yet completed at least 30days since ending other investigational device or drug trials

11. Investigator believe subject is not suitable for this study