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HEnagliflozin improves LV mass index of patients with Dialysis and HFpEF——a randomized, double blind, placebo controlled study

HEnagliflozin improves LV mass index of patients with Dialysis and HFpEF——a randomized, double blind, placebo controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073169
Enrollment
Unknown
Registered
2023-07-03
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialysis(peritoneal dialysis and hemodialysis)

Interventions

Henagliflozin group:Patients are given oral henagliflozin 5mg qd. If the patient cannot tolerate the dose, reduce to 2.5mg qd.
Placebo group:Patients are given oral placebo 5mg qd. If the patient cannot tolerate the dose, reduce to 0.5 tablets qd.

Sponsors

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Agree to join the study and sign the informed consent form. 2. 18-80 years old. 3. Hemodialysis patients with regular hemodialysis (including HD, HDF, HP) for more than 3 months. 4. Kt/V > 1.1 or UUR > 60% in a single hemodialysis within 3 months. 5. Peritoneal dialysis patients with regular CAPD, DAPD or APD for more than 3 months. 6. Kt/V =1.7 within 3 months in peritoneal dialysis patients. 7. Reach the diagnostic criteria of HFpEF [with symptoms of heart failure combined with one of the following: a) BNP > 300pg/ml or NT-proBNP > 8000pg / ml; b) left ventricular hypertrophy within 12 months (male > 110g/m2, female > 90g/m2); c) hospitalized due to heart failure within 1 year], and EF = 50%. 8. Patients with stable capacity load, and the BCM detection OH = 3.0. 9. The dose of anti-heart failure drugs (including RAS blocker, MRA, ß-blocker) is stable at least 4 weeks.

Exclusion criteria

Exclusion criteria: 1. Hypoglycemia occurs more than twice within 4 weeks. 2. Evidence of ketoacidosis within 3 months. 3. Patients with type 1 diabetes mellitus. 4. Hemoglobin 3.0). 8. Patients with systemic active infection. 9. Patients with uncured tumor. 10. Patients with symptoms of active genitourinary system infection. 11. Patients with history of cardiac valve replacement or repair operation. 12. Patients with history of persistent atrial fibrillation. 13. Patients allergic to henagliflozin. 14. Pregnant and lactating women. 15. Patients participating in other intervention studies. 16. Other conditions in which the investigators judge that the patient is not suitable for the study.

Design outcomes

Primary

MeasureTime frame
Left ventricular mass index, LVMI;

Secondary

MeasureTime frame
E/e’;NT-proBNP;

Countries

China

Contacts

Public ContactGu Leyi

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

guleyi@aliyun.com+86 139 1814 8433

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026