Ischemic Heart Failure
Conditions
Brief summary
The study will evaluate the efficacy of alpha-lipoic acid(α-LA) on mortality in patients with ischemic heart failure (NYHA Class II - IV and EF =\< 50%).
Interventions
DRUGAlpha-Lipoic Acid(α-LA)
200 mg, po, tid
DRUGPlacebos
200 mg, po, tid
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Had First Occurrence of the Composite Endpoint | up to 24 months | either all-cause death or heart failure (HF) hospitalization |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alpha-Lipoic Acid(α-LA) Double blind treatment period consisted of treatment with CHF standard treatments, followed by α-LA 200 mg tid over a total duration of 24 months.
Alpha-Lipoic Acid(α-LA): 200 mg, po, tid | 138 |
| Placebo Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months.
Placebos: 200 mg, po, tid | 139 |
| Total | 277 |
Baseline characteristics
| Characteristic | Alpha-Lipoic Acid(α-LA) | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 10.7 | 65.3 years STANDARD_DEVIATION 11.2 | 65.7 years STANDARD_DEVIATION 11.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 138 Participants | 277 Participants | 139 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 138 participants | 277 participants | 139 participants |
| Sex: Female, Male Female | 30 Participants | 59 Participants | 29 Participants |
| Sex: Female, Male Male | 108 Participants | 218 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 32 / 138 | 40 / 139 |
| other Total, other adverse events | 31 / 145 | 25 / 144 |
| serious Total, serious adverse events | 12 / 145 | 14 / 144 |
Outcome results
Primary
Number of Participants That Had First Occurrence of the Composite Endpoint
either all-cause death or heart failure (HF) hospitalization
Time frame: up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alpha-Lipoic Acid(α-LA) | Number of Participants That Had First Occurrence of the Composite Endpoint | 32 Participants |
| Placebo | Number of Participants That Had First Occurrence of the Composite Endpoint | 40 Participants |