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Recruiting NCT06249945

EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease

Phase IV Interventional Heart Failure With Preserved Ejection Fraction End Stage Renal Disease on Dialysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Empagliflozin 25 MG, Placebo.
Who it may be relevant to
Registry conditions: Heart Failure With Preserved Ejection Fraction, End Stage Renal Disease on Dialysis. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Safety and Efficacy of Empagliflozin in Patients With End-stage Renal Disease and Heart Failure With Preserved Ejection Fraction - a Randomized Controlled Trial

Overview

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.

Interventions

  • Drug Empagliflozin 25 MG
    The medication will be packed in a customized sealed jar and labeled on the exterior of the jar.
  • Drug Placebo
    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.

Primary outcome measures

  • Mitral early (E) and late (A) diastolic filling velocity ratio (E/A) [Time frame: 24 weeks of treatment]
Secondary outcome measures (12)
  • LV end-systolic volume index [Time frame: 12 weeks and 24 weeks of treatment]
  • LV end-diastolic volume index [Time frame: 12 weeks and 24 weeks of treatment]
  • LA volume index [Time frame: 12 weeks and 24 weeks of treatment]
  • LV ejection fraction [Time frame: 12 weeks and 24 weeks of treatment]
  • Left ventricular mass index [Time frame: 12 weeks and 24 weeks of treatment]
  • Global longitudinal strain [Time frame: 12 weeks and 24 weeks of treatment]
  • LA strain [Time frame: 12 weeks and 24 weeks of treatment]
  • Mitral inflow deceleration time [Time frame: 12 weeks and 24 weeks of treatment]
  • Mitral inflow deceleration time LV relative wall thickness [Time frame: 12 weeks and 24 weeks of treatment]
  • Tricuspid regurgitation peak gradient (TRPG) [Time frame: 12 weeks and 24 weeks of treatment]
  • NT-proBNP [Time frame: 4 weeks, 12 weeks and 24 weeks of treatment]
  • HbA1c [Time frame: 4 weeks, 12 weeks and 24 weeks of treatment]

Eligibility criteria

Inclusion criteria

  • Age ≥20 years old
  • ESRD under chronic, maintenance dialysis with stable dry weight for the past 6 months
  • Prior diagnosis of HFpEF, as defined by a score of ≥5 on the HFA-PEFF diagnostic algorithm.

Exclusion criteria

  • Age <20 years old
  • Ongoing pregnancy
  • NYHA class IV heart failure
  • Any hospitalization for heart failure within the past month Ongoing acute urinary tract infection at the time of screening
  • Known acute genital infection
  • Severe peripheral artery disease (Rutherford category 4-6)
  • Acute coronary syndrome, stroke or transient ischemic attack within the past month
  • Recent initiation of chronic maintenance hemodialysis within 6 months
  • Adjustment of dry weight with changes greater than 5% of body weight within the past month
  • Documented left ventricular ejection fraction =<40% by any imaging modality within 1 month of screening
  • Refused informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 2 centers
  • National Taiwan University Hospital Hsinchu Branch — Hsinchu
  • Shin Kong Wu Ho-Su Memorial Hospital — Taipei

Publications

  • 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. PMID 32061315
  • 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. PMID 34175022
  • 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. PMID 19007588
  • 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. PMID 31146814
  • 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 C PMID 31806133
  • 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. PMID 30361677
  • 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. PMID 31599363
  • 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. PMID 26861140

Identifiers

NCT: NCT06249945 · 202301126MINC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗