The Safety of Dapagliflozin in Hemodialysis Patients With Heart Failure
NCT ID: NCT05141552
Last Updated: 2022-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2022-01-03
2022-07-31
Brief Summary
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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-.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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dapa group
subjects will be treated with dapagliflozin (10mg per day) and standard anti-heart failure therapy (including RAS inhibitors, beta-blocker, Aldosterone inhibitors)
Dapagliflozin 10Mg Tab
In both group, subjects keep blood purification and anti heart failure treatment, including ARNI, RASi, Aldosterone inhibitors and beta receptor blocker.
control group
subjects will be treated with standard anti-heart failure therapy (including RAS inhibitors, beta-blocker, Aldosterone inhibitors)
No interventions assigned to this group
Interventions
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Dapagliflozin 10Mg Tab
In both group, subjects keep blood purification and anti heart failure treatment, including ARNI, RASi, Aldosterone inhibitors and beta receptor blocker.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Leyi Gu
Professor
Principal Investigators
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Leyi Gu
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Locations
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Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
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, Bohm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Juanatey JR, Kaul S, Brunner-La Rocca HP, Merkely B, Nicholls SJ, Perrone S, Pina I, Ponikowski P, Sattar N, Senni M, Seronde MF, Spinar J, Squire I, Taddei S, Wanner C, Zannad F; EMPEROR-Reduced Trial Investigators. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8;383(15):1413-1424. doi: 10.1056/NEJMoa2022190. Epub 2020 Aug 28.
McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm 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 JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
Singh M, Kumar A. Risks Associated with SGLT2 Inhibitors: An Overview. Curr Drug Saf. 2018;13(2):84-91. doi: 10.2174/1574886313666180226103408.
Other Identifiers
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KY2021-162
Identifier Type: -
Identifier Source: org_study_id
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