Chemotherapy induced cardiac toxicity reactions
Conditions
Interventions
Test group:Qingxin Formula+Basic Treatment
Control group:Basic Treatment
Sponsors
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following inclusion criteria in order to be enrolled in this study: 1. Patients with various types of tumors who experience one or more cardiac toxicity reactions such as heart failure, arrhythmia, angina pectoris, etc. after using chemotherapy drugs alone or in combination; 2. Age between 18-80 years old (including threshold), male or female not limited; 3. It conforms to the traditional Chinese medicine syndrome differentiation of "yin deficiency, toxin heat, qi deficiency, and blood stasis"; 4. Karnofsky functional status score (KPS score) = 60 points; 5. Can cooperate to complete the evaluation of cardiac function projects before and after each chemotherapy cycle; 6. Meets one or more of the following criteria (1) and meets one or more of criteria (2-4): (1) Symptoms or signs related to acute/chronic congestive heart failure (CHF); (2) LVEF = 50% and/or abnormal elevation of one of the myocardial biomarkers (cTnI, cTnT, CK-MB, NT proBNP, BNP); (3) Compared with before chemotherapy, LVEF decreased by = 10%, LVEF was 40% -49%, or LVEF decreased by500ms] and/or 24-hour dynamic electrocardiogram showed significant abnormalities [Lown grading criteria for ventricular premature beats grade 2 (including grade 2) or above]. 7. Those who meet the New York Heart Association (NYHA) grading criteria I-III; 8. Sign the informed consent form and agree to participate in the experimental study.
Exclusion criteria
Exclusion criteria: Subjects with any of the following conditions are not eligible for inclusion in this study: (1) Patients with severe arrhythmia diseases such as atrial fibrillation, atrial flutter, persistent supraventricular or ventricular tachycardia, and ventricular or bundle branch block; (2) Patients with combined acute coronary syndrome (within 30 days), cardiogenic shock, acute myocarditis, uncontrolled malignant arrhythmia, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, severe valve disease requiring surgical treatment, and pulmonary embolism; (3) Patients who have received defibrillation or cardiac resynchronization therapy within 12 weeks, or those who plan to receive this device within 12 weeks; (4) Currently undergoing chest radiation therapy; (5) Individuals with uncontrolled hypertension or hypotension; When sitting quietly, the systolic blood pressure should be = 180mmHg or<90mmHg, and the diastolic blood pressure should be = 120mmHg or<60mmHg; (6) Patients who have stopped anti-tumor chemotherapy for more than 1 year; (7) Pregnant women, those who are breastfeeding or preparing to conceive within six months; (8) Merge individuals with mental illnesses; (9) Simultaneously participating in other clinical trials; (10) Researchers believe that participants are not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CK-MB;cTNT;NYHA cardiac function classification;NT-proBNP;Traditional Chinese Medicine Syndrome Points; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of arrhythmias;CCS angina classification;electrocardiogram; | — |
Countries
China
Contacts
Public ContactRuihua Wang
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed