The Safety of Dapagliflozin in Hemodialysis Patients With Heart Failure

Study Overview
=================
Brief 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-.

Detailed Description
-----------------
Evaluate the safety of dapagliflozin in hemodialysis patients with heart failure is the main purpose of this study. and Estimate the change of NT-proBNP is the secondary purpose. This is a randomized, control and open study. The including criteria are 1. Understand the present study and sign informed consert 2. Age is between 18 and 70 3. 2 or 3 times blood purification treatments (inclusion hemodialysis, hemofiltration, hemoperfusion) every week, 4. Blood purification treatment more than 3 month 5. Using AV fistula or artificial vascular access 6. With chronic heart failure (NYHC II-IV), and NT-proBNP>11500 or BNP>500 7. ARNI or RAS inhibitor or Aldosterone inhibitors treatment for at least 4 weeks with a stable dose The exclusion criteria are 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 Subjects will divide into two groups. Dapa group will be treated with dapagliflozin 10mg qd and standard anti-heart failure therapy. Control group will be treated with standard anti-heart failure therapy. The primary outcome is the number of patients with hypoglycemia or urinary tract infection. The secondary outcome is the change of NT-proBNP

Official Title
-----------------
The Safety of Dapagliflozin in Hemodialysis Patients With Heart Failure

Conditions
-----------------
Hemodialysis Complication

Intervention / Treatment
-----------------
* Drug: Dapagliflozin 10Mg Tab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Understand the present studyAgree and sign informed consert Age is between 18 and 70 Men or women ≧18 years and <70 years of age at screening Treated with maintenance blood purification 2 or 3 times blood purification treatments (including hemodialysis, hemofiltration, hemoperfusion) every week2 or 3 times a week, Blood purification treatment more than 3 month before randomization Blood purification by uUsing AV fistula or artificial vascular access DiagnosisWith chronic heart failure (NYHC II-IV), and NT-proBNP>11500 or BNP>500 ARNI or RAS inhibitor or Aldosterone inhibitors or beta receptor blocker treatment for at least 4 weeks with a stable dose. Exclusion Criteria: Blood purification less than 3 month With fluid overload and URR<50% Have severe hypoglycemia (more than 2 events with 4 weeks prior to sign concert information) Have severe hypotension (blood pressure <90/60mmHg more than 3 times with 4 weeks prior to sign concert information) Have acute pulmonary edema Have ketoacidosis Have active pyelnephritis and symptomatic lower urinary infection Subject is pregnant , is breast feeding Subject has known SGLT2 inhibitor allergy or intolerance adverse reactions Subject is currentluy enrolled in or has not yet completed at least 30days since ending other investigational device or drug trials Investigator believe subject is not suitable for this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dapa group<br>subjects will be treated with dapagliflozin (10mg per day) and standard anti-heart failure therapy (including RAS inhibitors, beta-blocker, Aldosterone inhibitors) | Drug: Dapagliflozin 10Mg Tab<br>* In both group, subjects keep blood purification and anti heart failure treatment, including ARNI, RASi, Aldosterone inhibitors and beta receptor blocker.<br>* Other names: Control;|
| No Intervention: control group<br>subjects will be treated with standard anti-heart failure therapy (including RAS inhibitors, beta-blocker, Aldosterone inhibitors) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of patients with hypoglycemia or urinary tract infection | the number of patients with hypoglycemia or urinary tract infection | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of NT-proBNP | Change of NT-proBNP | 12 weeks |