Intervention effect of Yi Qi Wen Yang decoction on cardiac damage of anthracycline chemotherapeutic drugs

Phase 1

• Conditions: Anthracycline heart damage

• Registration Number: ChiCTR2400088740
• Lead Sponsor: Jiangsu Provincial Hospital of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Trial and disease control groups:<br>1. patients with a primary diagnosis of diffuse large B-cell lymphoma using an anthracycline-containing chemotherapy regimen or combination radiotherapy;<br>2. aged 18-80 years;<br>3. NYHA cardiac class I;<br>4. left ventricular ejection fraction (LVEF) >50%;<br>5. normal baseline electrocardiogram, cardiac enzyme profile, troponin, and NT-proBNP/BNP;<br>6. no diabetes mellitus or organic cardiovascular disease;<br>7. be classified as Yang deficiency and water flooding in Chinese medicine;<br>8. voluntarily participate in the study, perform auxiliary examinations and follow-up visits according to the established plan, be approved by the Ethics Committee of the hospital, and sign the informed consent form, which is in accordance with the relevant provisions of the Good Practice in Drug Clinical Trials (GCP).<br>Blank control group:<br>1. aged 18-80 years old;<br>2. no history of tumour; 3. cardiac ultrasound showing left ventricular ejection<br>3. left ventricular ejection fraction (LVEF) >50% on cardiac ultrasound, with no cardiac structural and functional abnormalities;<br>4. no other organic cardiovascular diseases;<br>5. no history of diabetes mellitus<br>6. require 18F-FDG PET/CT for disease screening;<br>7. participate voluntarily in the study, perform auxiliary examinations and follow-up visits according to the established plan, be approved by the Ethics Committee of the hospital, and sign the informed consent form, which is in accordance with the relevant provisions of the Good Practice in Drug Clinical Trials (GCP).

Exclusion Criteria

Trial and disease control groups:<br>1. persons younger than 18 years or older than 80 years;<br>2. patients with diabetes mellitus and organic cardiovascular diseases;<br>3. patients with acute inflammation, infection, myocardial ischaemia, etc. affecting myocardial glucose uptake;<br>4. patients with disabilities and a history of drug and alcohol abuse;<br>5. patients who have used other western and Chinese medicines for the treatment of cardiac damage by chemotherapeutic drugs after the current episode;<br>6. patients who are unable to co-operate with the study or who have intellectual or psychiatric disorders;<br>7. patients participating in other clinical trials;<br>8. pregnant and breastfeeding women, patients in preparation for pregnancy;<br>9. patients with serious primary heart, liver, lung, kidney, blood or serious diseases affecting their survival, such as liver cancer, renal failure, leukaemia, etc;<br>10. allergy, such as allergic to two or more drugs or food; or known allergy to the ingredients of this drug. <br>Blank control group:<br>1. persons younger than 18 years old and older than 80 years old;<br>2. patients with tumours;<br>3. left ventricular ejection fraction (LVEF) <50% on cardiac ultrasound or with structural or functional cardiac abnormalities;<br>4. diabetes mellitus, organic cardiovascular disease;<br>5. patients with acute inflammation, infection, myocardial ischaemia and other conditions that affect myocardial glucose uptake;<br>6. patients with disabilities, history of drug and alcohol abuse;<br>7. pregnant and breastfeeding women, patients in preparation for pregnancy;<br>8. patients who are unable to co-operate with the study or have intellectual or psychiatric disorders;<br>9. patients participating in other clinical trials<br>10. allergy, such as allergy to two or more drugs or food; or known allergy to 18F-FDG.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SUVmax, SUVmean;Serum OLINK proteomic;

Secondary Outcome Measures

Name	Time	Method
Cardiac ultrasound speckle tracking GLS values;cardiac ultrasound indicators;Myocardial Enzyme Profile;Chinese Medicine Score;6-minute walk test;NYHA class;Serum Q300 Targeted Metabolomics ;NT-proBNP/BNP;