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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT03491969
Eligibility Criteria:
Inclusion Criteria:
* patients ≥ 18 years of age, male or female.
* Patients with a diagnosis of AMI (\>30 days) according to the global definition. ③Patients with a diagnosis of CHF (NYHA class II-IV) and reduced ejection fraction (EF =\< 50%) and elevated BNP（NT-proBNP≥600pg/ml or BNP≥150pg/ml; NT-proBNP ≥400 pg/mL or BNP ≥100 pg/mL if patients was hospitalized for heart failure within 12months).
* Patients must be treated with standardized heart failure medications treatment at a stable dose for at least 4 weeks.
* Patients must give written informed consent before any assessment is performed.
Exclusion Criteria:
* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
* allergy to any of the study drugs, drugs of similar chemical classes（Vitamin B） as well as known or suspected contraindications to the study drugs.
* Previous history of intolerance to recommended target doses of α-LA.
* Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).
⑤ Symptomatic hypotension and/or a SBP \< 100 mmHg.
⑥ Severe liver function abnormalities (ALT or AST more than 3 times of the normal upper limit).
⑦ Estimated GFR \< 30 mL/min/1.73m2 as measured by the simplified MDRD formula.
⑧ Serum potassium \> 5.2 mmol/L.
⑨ Pregnant women or women preparing for birth.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03491969
Study Brief:
Protocol Section:
NCT03491969