The Safety of Dapagliflozin in Hemodialysis Patients With Heart Failure

Hemodialysis Complication Clinical Trial

— SDHF  

Official title:

The Safety of Dapagliflozin in Hemodialysis Patients With Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05141552
• Other study ID #: KY2021-162
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: July 31, 2022

Study information

• Verified date: May 2022
• Source: RenJi Hospital
• Contact: Leyi Gu
• Phone: 86-21-58752345
• Email: guleyi[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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-.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Hemodialysis Complication

Intervention

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.

Locations

Country	Name	City	State
China	Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Böhm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray — View Citation

McMurray JJV, Solomon SD, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlávek J, Böhm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukát A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman C — View Citation

Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, Januzzi J, Verma S, Tsutsui H, Brueckmann M, Jamal W, Kimura K, Schnee J, Zeller C, Cotton D, Bocchi E, Böhm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Jua — View Citation

Singh M, Kumar A. Risks Associated with SGLT2 Inhibitors: An Overview. Curr Drug Saf. 2018;13(2):84-91. doi: 10.2174/1574886313666180226103408. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of patients with hypoglycemia or urinary tract infection	the number of patients with hypoglycemia or urinary tract infection	12 weeks
Secondary	Change of NT-proBNP	Change of NT-proBNP	12 weeks