Heart Failure With Preserved Ejection Fraction Clinical Trial
— EMPA-PREDOfficial 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
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.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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National Taiwan University Hospital | Shin Kong Wu Ho-Su Memorial Hospital |
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | LV end-systolic volume index | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment | |
Secondary | LV end-diastolic volume index | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment | |
Secondary | LA volume index | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment | |
Secondary | LV ejection fraction | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment | |
Secondary | Left ventricular mass index | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment | |
Secondary | Global longitudinal strain | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment | |
Secondary | LA strain | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment | |
Secondary | Mitral inflow deceleration time | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment | |
Secondary | Mitral inflow deceleration time LV relative wall thickness | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment | |
Secondary | Tricuspid regurgitation peak gradient (TRPG) | As assessed by echocardiography, performed on non-dialysis day | 12 weeks and 24 weeks of treatment | |
Secondary | NT-proBNP | Blood tests obtained pre-dialysis session | 4 weeks, 12 weeks and 24 weeks of treatment | |
Secondary | HbA1c | Blood tests obtained pre-dialysis session | 4 weeks, 12 weeks and 24 weeks of treatment | |
Secondary | Lipid profile | Blood tests obtained pre-dialysis session | 4 weeks, 12 weeks and 24 weeks of treatment | |
Secondary | KCCQ-OS | Performed on non-dialysis day | 12 weeks and 24 weeks of treatment | |
Secondary | 6-minute walking distance | Performed on non-dialysis day | 12 weeks and 24 weeks of treatment | |
Secondary | 3-minute heart rate variability | During hemodialysis session | 12 weeks and 24 weeks of treatment | |
Secondary | Blood pressure | Obtained pre-dialysis session | 12 weeks and 24 weeks of treatment | |
Secondary | Major adverse cardiovascular events (composite of CV death, myocardial infarction, stroke) | By medical record confirmation and by interview | 24 weeks of treatment | |
Secondary | Lower extremity non-traumatic amputation or revascularization | By medical record confirmation and by interview | 24 weeks of treatment | |
Secondary | All-cause mortality | By medical record confirmation and by interview | 24 weeks of treatment | |
Secondary | Hospitalization for heart failure | By medical record confirmation and by interview | 24 weeks of treatment | |
Secondary | Hypoglycemic events | By medical record confirmation and by interview | 24 weeks of treatment | |
Secondary | Diabetic ketoacidosis | By medical record confirmation and by interview | 24 weeks of treatment | |
Secondary | Urinary tract infection | By medical record confirmation and by interview | 24 weeks of treatment | |
Secondary | Genital tract infection | By medical record confirmation and by interview | 24 weeks of treatment | |
Secondary | Hypokalemia | Blood tests obtained pre-dialysis session | 4 weeks, 12 weeks and 24 weeks of treatment |
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