Investigating the Clinical Benefits and Underlying Mechanisms of Danhong Injection in Modulating Mitochondrial Homeostasis Against Sepsis-Associated Myocardial Dysfunction

Starting soon · Phase 2

Conditions studied: Sepsis-Induced Myocardial Dysfunction

In brief

This study aims to evaluate the clinical efficacy of Danhong injection in patients with septic myocardial injury through a prospective randomized controlled trial. The study will enroll 140 patients meeting criteria for septic myocardial injury, divided into a Danhong injection group and a placebo group. Primary endpoints include changes in myocardial injury markers and improvement rates in cardiac function over 7 days, while secondary endpoints include 28-day mortality rates. This will determine whether Danhong injection possesses myocardial protective effects and provide evidence-based support for expanding its clinical indications.

Key facts

Study ID

NCT07375862

Run by

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

People needed

140

Starts

2026-07-01

Expected to finish

2028-12-01

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who met the Sepsis-3 criteria, defined by a suspected or confirmed infection and an increase in the Sequential Organ Failure Assessment (SOFA) score of 2 points or more from baseline.
• Patients with a diagnosis of sepsis-induced myocardial dysfunction (SIMD).

You may not qualify if…

• Patients with significant primary cardiac diseases, including unstable coronary artery disease, severe cardiomyopathy, or severe valvular heart disease.
• Exclusion criteria included long-term use of Danhong Injection or recent use of other medication with potential significant impact on cardiac function.
• Patients with severe hepatic dysfunction (defined as Child-Pugh class C) or severe renal insufficiency (defined as creatinine clearance <30 mL/min) were excluded.
• Patients with a known allergy to any component of Danhong Injection or a history of severe allergic diathesis were excluded.
• Pregnant or lactating women
• Patients with severe mental illness or inability to cooperate with the study.
• Participation in other drug clinical trials within 3 months prior to enrollment.

Full record on ClinicalTrials.gov

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