Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT04950569
Eligibility Criteria:
Inclusion Criteria:
1. Age over 18 years old, no gender limit;
2. A clear diagnosis of chronic systolic heart failure with heart function NYHA III-IV (including medical history, clinical symptoms, and signs) by two attending physicians or above the level of attending ;
3. Left ventricular ejection fraction (LVEF) \<40%;
4. Plasma NT-proBNP\>1000 ng/L;
5. Participate voluntarily and sign an informed consent form, and can be followed up for more than 6 months.
Exclusion Criteria:
1. NYHA Class I-II of cardiac function;
2. Acute myocardial infarction occurred in the past month;
3. Unstable angina pectoris;
4. Patients with acute pulmonary edema or acute hemodynamic disturbance;
5. Right heart failure due to lung disease;
6. Patients who are going to undergo heart transplantation or cardiac resynchronization therapy (CRT), or those who have received CRT treatment;
7. Female patients who have or plan to become pregnant;
8. Those who have participated in any drug clinical trials within the previous 3 months;
9. Those who have a history of tumors or are currently suffering from tumors, or pathological examinations have confirmed precancerous lesions (such as ductal carcinoma in situ of the breast, or dysplasia of the cervix);
10. Patients who was detected with a malignant mass in the body through examination (physical examination, or X-ray examination or B-ultrasound examination or other means), or detected with a hyperplastic gland or adenoma that has endocrine activity and affects heart function or endocrine function, such as pheochromocytoma, etc.;
11. The patient refused to comply with the requirements of this research to complete the research work;
12. According to the judgment of the investigator, the patient cannot complete the study or cannot comply with the requirements of the study (due to management reasons or other reasons).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04950569
Study Brief:
Protocol Section:
NCT04950569