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| Name | Class |
|---|---|
| Shin Kong Wu Ho-Su Memorial Hospital | OTHER |
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The presence of CKD has been linked to the development of HFpEF. Currently, the treatment for HFpEF is limited. SGLT2i are one of the few drug classes that have proven efficacy in HFpEF in randomized controlled trials. The results of mechanistic studies suggest that the benefits of SGLT2i on diastolic heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Despite the significance of HFpEF in patients with CKD, patients with advanced kidney disease have been excluded from studies investigating anti-heart failure drugs. The effects of SGLT2i in patients under maintenance dialysis are largely unknown. Past pharmacokinetics and pharmacodynamics studies on empagliflozin in patients with end-stage renal disease (ESRD) demonstrated that the use of empagliflozin in patients with ESRD seemed safe, yet its efficacy remains to be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| empagliflozin | Experimental | Jardiance, 25 mg, QD, for 6 months |
|
| Placebo | Placebo Comparator | QD, for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 25 MG | Drug | The medication will be packed in a customized sealed jar and labeled on the exterior of the jar. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mitral early (E) and late (A) diastolic filling velocity ratio (E/A) | As assessed by echocardiography, performed on non-dialysis day | 24 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| LV end-systolic volume index | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment |
| LV end-diastolic volume index | As assessed by echocardiography, performed on non-dialysis day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donna SH Lin, MD | Contact | +886912902379 | Donna.lin24@gmail.com | |
| Hao-Yun Lo, MD | Contact | +886972234640 | limoonby@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Donna SH Lin, MD | Shin Kong Wu Ho-Su Memorial Hospital | Principal Investigator |
| Chih-Cheng Wu, MD. PhD | National Taiwan University Hsin-Chu Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital Hsinchu Branch | Recruiting | Hsinchu | 300 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32061315 | Background | GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13. | |
| 34175022 | Background | Kalantar-Zadeh K, Jafar TH, Nitsch D, Neuen BL, Perkovic V. Chronic kidney disease. Lancet. 2021 Aug 28;398(10302):786-802. doi: 10.1016/S0140-6736(21)00519-5. Epub 2021 Jun 24. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| Placebo | Drug | The placebo tablet is manufactured by Prince Pharmaceutical Co., Ltd, a leading manufacturer of nutritional supplements with certifications including cGMP, GMP, ISO, and HACCP. The Prince Pharmaceutical also provides Original Equipment Manufacturing (OEM)/Original Design Manufacturing (ODM) services for a wide array of tablet shapes, and post-processing techniques such as film coating and sugar coating. |
|
| 12 weeks and 24 weeks of treatment |
| LA volume index | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment |
| LV ejection fraction | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment |
| Left ventricular mass index | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment |
| Global longitudinal strain | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment |
| LA strain | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment |
| Mitral inflow deceleration time | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment |
| Mitral inflow deceleration time LV relative wall thickness | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment |
| Tricuspid regurgitation peak gradient (TRPG) | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment |
| NT-proBNP | Blood tests obtained pre-dialysis session | 4 weeks, 12 weeks and 24 weeks of treatment |
| HbA1c | Blood tests obtained pre-dialysis session | 4 weeks, 12 weeks and 24 weeks of treatment |
| Lipid profile | Blood tests obtained pre-dialysis session | 4 weeks, 12 weeks and 24 weeks of treatment |
| KCCQ-OS | Performed on non-dialysis day | 12 weeks and 24 weeks of treatment |
| 6-minute walking distance | Performed on non-dialysis day | 12 weeks and 24 weeks of treatment |
| 3-minute heart rate variability | During hemodialysis session | 12 weeks and 24 weeks of treatment |
| Blood pressure | Obtained pre-dialysis session | 12 weeks and 24 weeks of treatment |
| Major adverse cardiovascular events (composite of CV death, myocardial infarction, stroke) | By medical record confirmation and by interview | 24 weeks of treatment |
| Lower extremity non-traumatic amputation or revascularization | By medical record confirmation and by interview | 24 weeks of treatment |
| All-cause mortality | By medical record confirmation and by interview | 24 weeks of treatment |
| Hospitalization for heart failure | By medical record confirmation and by interview | 24 weeks of treatment |
| Hypoglycemic events | By medical record confirmation and by interview | 24 weeks of treatment |
| Diabetic ketoacidosis | By medical record confirmation and by interview | 24 weeks of treatment |
| Urinary tract infection | By medical record confirmation and by interview | 24 weeks of treatment |
| Genital tract infection | By medical record confirmation and by interview | 24 weeks of treatment |
| Hypokalemia | Blood tests obtained pre-dialysis session | 4 weeks, 12 weeks and 24 weeks of treatment |
| Shin Kong Wu Ho-Su Memorial Hospital | Recruiting | Taipei | 111 | Taiwan |
|
| 19007588 | Background | Ronco C, Haapio M, House AA, Anavekar N, Bellomo R. Cardiorenal syndrome. J Am Coll Cardiol. 2008 Nov 4;52(19):1527-39. doi: 10.1016/j.jacc.2008.07.051. |
| 31146814 | Background | Bansal N, Zelnick L, Bhat Z, Dobre M, He J, Lash J, Jaar B, Mehta R, Raj D, Rincon-Choles H, Saunders M, Schrauben S, Weir M, Wright J, Go AS; CRIC Study Investigators. Burden and Outcomes of Heart Failure Hospitalizations in Adults With Chronic Kidney Disease. J Am Coll Cardiol. 2019 Jun 4;73(21):2691-2700. doi: 10.1016/j.jacc.2019.02.071. |
| 31806133 | Background | Kotecha D, Gill SK, Flather MD, Holmes J, Packer M, Rosano G, Bohm M, McMurray JJV, Wikstrand J, Anker SD, van Veldhuisen DJ, Manzano L, von Lueder TG, Rigby AS, Andersson B, Kjekshus J, Wedel H, Ruschitzka F, Cleland JGF, Damman K, Redon J, Coats AJS; Beta-Blockers in Heart Failure Collaborative Group. Impact of Renal Impairment on Beta-Blocker Efficacy in Patients With Heart Failure. J Am Coll Cardiol. 2019 Dec 10;74(23):2893-2904. doi: 10.1016/j.jacc.2019.09.059. |
| 30361677 | Background | Ferro CJ, Mark PB, Kanbay M, Sarafidis P, Heine GH, Rossignol P, Massy ZA, Mallamaci F, Valdivielso JM, Malyszko J, Verhaar MC, Ekart R, Vanholder R, London G, Ortiz A, Zoccali C. Lipid management in patients with chronic kidney disease. Nat Rev Nephrol. 2018 Dec;14(12):727-749. doi: 10.1038/s41581-018-0072-9. |
| 31599363 | Background | Shah KS, Fang JC. Is Heart Failure with Preserved Ejection Fraction a Kidney Disorder? Curr Hypertens Rep. 2019 Oct 10;21(11):86. doi: 10.1007/s11906-019-0993-0. |
| 26861140 | Background | Ter Maaten JM, Damman K, Verhaar MC, Paulus WJ, Duncker DJ, Cheng C, van Heerebeek L, Hillege HL, Lam CS, Navis G, Voors AA. Connecting heart failure with preserved ejection fraction and renal dysfunction: the role of endothelial dysfunction and inflammation. Eur J Heart Fail. 2016 Jun;18(6):588-98. doi: 10.1002/ejhf.497. Epub 2016 Feb 10. |
| 31926856 | Background | Cohen JB, Schrauben SJ, Zhao L, Basso MD, Cvijic ME, Li Z, Yarde M, Wang Z, Bhattacharya PT, Chirinos DA, Prenner S, Zamani P, Seiffert DA, Car BD, Gordon DA, Margulies K, Cappola T, Chirinos JA. Clinical Phenogroups in Heart Failure With Preserved Ejection Fraction: Detailed Phenotypes, Prognosis, and Response to Spironolactone. JACC Heart Fail. 2020 Mar;8(3):172-184. doi: 10.1016/j.jchf.2019.09.009. Epub 2020 Jan 8. |
| 34449189 | Background | Anker SD, Butler J, Filippatos G, Ferreira JP, Bocchi E, Bohm M, Brunner-La Rocca HP, Choi DJ, Chopra V, Chuquiure-Valenzuela E, Giannetti N, Gomez-Mesa JE, Janssens S, Januzzi JL, Gonzalez-Juanatey JR, Merkely B, Nicholls SJ, Perrone SV, Pina IL, Ponikowski P, Senni M, Sim D, Spinar J, Squire I, Taddei S, Tsutsui H, Verma S, Vinereanu D, Zhang J, Carson P, Lam CSP, Marx N, Zeller C, Sattar N, Jamal W, Schnaidt S, Schnee JM, Brueckmann M, Pocock SJ, Zannad F, Packer M; EMPEROR-Preserved Trial Investigators. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. 2021 Oct 14;385(16):1451-1461. doi: 10.1056/NEJMoa2107038. Epub 2021 Aug 27. |
| 31434508 | Background | Verma S, Mazer CD, Yan AT, Mason T, Garg V, Teoh H, Zuo F, Quan A, Farkouh ME, Fitchett DH, Goodman SG, Goldenberg RM, Al-Omran M, Gilbert RE, Bhatt DL, Leiter LA, Juni P, Zinman B, Connelly KA. Effect of Empagliflozin on Left Ventricular Mass in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease: The EMPA-HEART CardioLink-6 Randomized Clinical Trial. Circulation. 2019 Nov 19;140(21):1693-1702. doi: 10.1161/CIRCULATIONAHA.119.042375. Epub 2019 Aug 22. |
| 34669059 | Background | Ersboll M, Jurgens M, Hasbak P, Kjaer A, Wolsk E, Zerahn B, Brandt-Jacobsen NH, Gaede P, Rossing P, Faber J, Inzucchi SE, Gustafsson F, Schou M, Kistorp C. Effect of empagliflozin on myocardial structure and function in patients with type 2 diabetes at high cardiovascular risk: the SIMPLE randomized clinical trial. Int J Cardiovasc Imaging. 2022 Mar;38(3):579-587. doi: 10.1007/s10554-021-02443-5. Epub 2021 Oct 20. |
| 34334588 | Background | Soga F, Tanaka H, Tatsumi K, Mochizuki Y, Sano H, Toki H, Matsumoto K, Shite J, Takaoka H, Doi T, Hirata KI. Impact of Dapagliflozin on the Left Ventricular Diastolic Function in Diabetic Patients with Heart Failure Complicating Cardiovascular Risk Factors. Intern Med. 2021;60(15):2367-2374. doi: 10.2169/internalmedicine.6127-20. Epub 2021 Aug 1. |
| 33719499 | Background | Li X, Lu Q, Qiu Y, do Carmo JM, Wang Z, da Silva AA, Mouton A, Omoto ACM, Hall ME, Li J, Hall JE. Direct Cardiac Actions of the Sodium Glucose Co-Transporter 2 Inhibitor Empagliflozin Improve Myocardial Oxidative Phosphorylation and Attenuate Pressure-Overload Heart Failure. J Am Heart Assoc. 2021 Mar 16;10(6):e018298. doi: 10.1161/JAHA.120.018298. Epub 2021 Mar 13. |
| 30328645 | Background | Pabel S, Wagner S, Bollenberg H, Bengel P, Kovacs A, Schach C, Tirilomis P, Mustroph J, Renner A, Gummert J, Fischer T, Van Linthout S, Tschope C, Streckfuss-Bomeke K, Hasenfuss G, Maier LS, Hamdani N, Sossalla S. Empagliflozin directly improves diastolic function in human heart failure. Eur J Heart Fail. 2018 Dec;20(12):1690-1700. doi: 10.1002/ejhf.1328. Epub 2018 Oct 17. |
| 23859488 | Background | Macha S, Mattheus M, Halabi A, Pinnetti S, Woerle HJ, Broedl UC. Pharmacokinetics, pharmacodynamics and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in subjects with renal impairment. Diabetes Obes Metab. 2014 Mar;16(3):215-22. doi: 10.1111/dom.12182. Epub 2013 Aug 19. |
| 31504452 | Background | Pieske B, Tschope C, de Boer RA, Fraser AG, Anker SD, Donal E, Edelmann F, Fu M, Guazzi M, Lam CSP, Lancellotti P, Melenovsky V, Morris DA, Nagel E, Pieske-Kraigher E, Ponikowski P, Solomon SD, Vasan RS, Rutten FH, Voors AA, Ruschitzka F, Paulus WJ, Seferovic P, Filippatos G. How to diagnose heart failure with preserved ejection fraction: the HFA-PEFF diagnostic algorithm: a consensus recommendation from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC). Eur Heart J. 2019 Oct 21;40(40):3297-3317. doi: 10.1093/eurheartj/ehz641. |
| 33413355 | Background | Rau M, Thiele K, Hartmann NK, Schuh A, Altiok E, Mollmann J, Keszei AP, Bohm M, Marx N, Lehrke M. Empagliflozin does not change cardiac index nor systemic vascular resistance but rapidly improves left ventricular filling pressure in patients with type 2 diabetes: a randomized controlled study. Cardiovasc Diabetol. 2021 Jan 7;20(1):6. doi: 10.1186/s12933-020-01175-5. |
| 33186508 | Background | Shim CY, Seo J, Cho I, Lee CJ, Cho IJ, Lhagvasuren P, Kang SM, Ha JW, Han G, Jang Y, Hong GR. Randomized, Controlled Trial to Evaluate the Effect of Dapagliflozin on Left Ventricular Diastolic Function in Patients With Type 2 Diabetes Mellitus: The IDDIA Trial. Circulation. 2021 Feb 2;143(5):510-512. doi: 10.1161/CIRCULATIONAHA.120.051992. Epub 2020 Nov 13. No abstract available. |
| 34939776 | Background | Junger C, Prochaska JH, Gori T, Schulz A, Binder H, Daiber A, Koeck T, Rapp S, Lackner KJ, Munzel T, Wild PS. Rationale and design of the effects of EMpagliflozin on left ventricular DIAstolic function in diabetes (EmDia) study. J Cardiovasc Med (Hagerstown). 2022 Mar 1;23(3):191-197. doi: 10.2459/JCM.0000000000001267. |
| 31780586 | Background | Jurgens M, Schou M, Hasbak P, Kjaer A, Wolsk E, Zerahn B, Wiberg M, Brandt NH, Gaede PH, Rossing P, Faber J, Inzucchi S, Gustafsson F, Kistorp CM. Design of a randomised controlled trial of the effects of empagliflozin on myocardial perfusion, function and metabolism in type 2 diabetes patients at high cardiovascular risk (the SIMPLE trial). BMJ Open. 2019 Nov 27;9(11):e029098. doi: 10.1136/bmjopen-2019-029098. |
| 40855136 | Derived | Lin DS, Lo HY, Yang CW, Wu CC. Safety and Short-Term Effects of Empagliflozin in Patients with Heart Failure and End-Stage Renal Disease. Am J Cardiovasc Drugs. 2026 Jan;26(1):83-96. doi: 10.1007/s40256-025-00760-x. Epub 2025 Aug 25. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |