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Shenzhuo formula and kidney outcomes in type 2 diabetic kidney disease Patients with heart failure with mildly reduced or preserved ejection fraction --a multicenter, randomized, double-blind, placebo control clinical trial

Shenzhuo formula and kidney outcomes in type 2 diabetic kidney disease Patients with heart failure with mildly reduced or preserved ejection fraction --a multicenter, randomized, double-blind, placebo control clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002032
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-10-31
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Type 2 diabetic nephropathy with heart failure and mildly reduced or preserved ejection fraction

Interventions

Renal Turbidity Formula Group:Oral Shen Zhuo Fang water pill formulation (12g per bag), three times daily, one bag each time.
Placebo group:Orally administered placebo identical in appearance, dosage and administration same as the Shenzhuo formula group.

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Agree to participate with an age greater than 18 years at the time of enrollment; 2. Meet the diagnostic criteria for Type 2 DKD; 3. 30 = eGFR 40% with evidence of structural heart disease; 3) NT-proBNP = 300 pg/mL (without atrial fibrillation) or = 600 pg/mL (with persistent atrial fibrillation); 6. Have been on ACEI/ARB therapy for more than 4 weeks; 7. Chinese medical diagnosis consistent with Qi deficiency and blood stasis syndrome; 8. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Allergy tocomponents; 2. Use of othertreatments for DKD/heart failure for less than 2 weeks; 3. Combined use of ACEI/ARB; 4. Type 1 diabetes; 5. HbA1c > 12%; 6. Serum potassium > 5.5 mmol/L; 7. Non-DKD kidney disease; 8. Acute kidney injury within the past 12 weeks; 9. History of kidney transplantation or planned transplantation; 10. Uncontrolled hypertension (SBP = 170 mmHg or DBP = 100 mmHg); 11. Hypotension (SBP 3 times the normal value); 23. Life expectancy < 12 months; 24. Pregnancy/breastfeeding; 25. Recent participation in other clinical trials; 26. History of drug abuse; 27. Investigator's judgment of unsuitability.

Design outcomes

Primary

MeasureTime frame
Estimated glomerular filtration rate (eGFR) slope;—

Secondary

MeasureTime frame
Difference in the ratio of urinary protein to creatinine(uacr);Heart failure exacerbation;N-terminal pro-B-type natriuretic peptide (NT-proBNP);Kansas City Cardiomyopathy Questionnaire (KCCQ) Score;TCM Syndrome Score;—

Countries

China

Contacts

Public ContactFan Ying

Shanghai Sixth People's Hospital

fanyingsh@126.com18930173178

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026