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 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT06377761
Eligibility Criteria:
Inclusion Criteria:
1. Sign the informed consent form
2. Age 18-85 years old
3. Heart failure was diagnosed ≥ 3 months before enrollment, The heart function classification II-IV of New York Heart Association (NYHA)
4. has ≥ 1 of the following: 1） Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) recorded by echocardiography at the time of enrollment；2）Hospitalization due to heart failure within 12 months before enrollment
5. Retention of ejection fraction: left ventricular ejection fraction (LVEF)≥50% (Echocardiography)
6. Increase of NTpro-BNP (patients without atrial fibrillation\>220pg/mL, patients with atrial fibrillation\>660pg/mL
7. If diuretics are being administered orally, the dose must be stable for ≥ 2 weeks before inclusion in the study
8. At the time of randomization, it was clinically stable without signs of decompensation of cardiac failure (judged by the investigator)
Exclusion Criteria:
1. Patients with decompensated heart failure
2. Glomerular filtration rate (eGFR)\<30mL/min/1.73m 2
3. Atrial fibrillation or atrial flutter with obvious liver disease or ALT, AST 3 times higher than the upper limit of normal
4. Symptomatic hypotension or systolic blood pressure (SBP)\<100mmHg at the time of inclusion or baseline
5. Resting heart rate recorded by echocardiography at the time of screening\>110bpm
6. Currently participating in another research equipment or drug test, or less than 30 days after the completion of another research equipment or drug test or receiving other research treatment. Patients participating in purely observational trials will not be excluded
7. At present, people who are taking traditional Chinese medicine or Chinese patent medicine with similar effect to Qishen Granules
8. Be allergic to any component of Qishen granules (astragalus membranaceus, salvia miltiorrhiza, and black aconite)
9. Patients who refuse to sign the informed consent form or estimate poor compliance and women who are pregnant, nursing or planning to become pregnant during the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06377761
Study Brief:
Protocol Section:
NCT06377761