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The preventive effect of SGLT2i on cardiovascular events in diabetic population based on natriuretic peptide selection

A multicenter, randomized, open-label study on the effectiveness of SGLT2 inhibitors in diabetes mellitus with elevated natriuretic peptides

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048160
Enrollment
Unknown
Registered
2021-07-04
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-03-14

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

Conditions

Type 2 diabetic mellitus

Interventions

Experimental group:Conventional treatment and SGLT2i
Control group:Conventional treatment

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 50 to 80 years; 2. The history of type 2 diabetic mellitus with HbA1c 7-10%; 3. NT-proBNP >= 125pg/ml with sinus rhythm or NT-proBNP >=375pg/ml with atrial fibrillation; 4. No history of heart failure; 5. Willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Have a clear history of heart failure or be diagnosed with heart failure before enrollment; 2. Have a history of malignant tumor; 3. History of chronic infectious diseases; 4. Suffering from systemic diseases using hormone therapy; 5. Severe hepatic and renal insufficiency (including renal replacement therapy); 6. Severe cognitive impairment or dementia; 7. Life expectancy is less than 1 year; 8. Are using SGLT2 inhibitors as well as pioglitazone and rosiglitazone; 9. Patients with type 1 diabetes; 10. Those with positive blood or urine ketone bodies; 11. Women in pregnancy; 12. Participating in other interventional studies.

Design outcomes

Primary

MeasureTime frame
The change of N-terminal natriuretic peptide precursor;

Secondary

MeasureTime frame
Glycated hemoglobin;Microalbuminuria;Vascular endothelial function;Echocardiography;

Countries

China

Contacts

Public ContactZhou Jingmin

Zhongshan Hospital, Fudan University

zhou.jingmin@zs-hospital.sh.cn+86 21 64041990

Outcome results

None listed

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