Heart failure after ST-elevation myocardial infarction
Conditions
Interventions
Test group 1:Coenzyme I for injection, 200 mg qd, administered continuously for 7 days
Test group 2:Coenzyme I for injection, 500mg qd, administered continuously for 7 days
Placebo group:Normal saline, 250 ml qd, administered continuously for 7 days
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Voluntarily participate and sign the informed consent form. (2) Age >= 18 years old at the time of screening, 450 ng/L in patients under the age of 50, and > at the age of 50~85 900ng/L; 3) Left ventricular ejection fraction (LVEF) <= 55%; (6) Male or female subjects who meet any of the following conditions: 1) Women of non-childbearing potential, especially those who have had hysterectomy, or bilateral oophorectomy, or bilateral tubal ligation, or are postmenopausal; 2) Female subjects of childbearing potential who must have a negative blood pregnancy test result within 7 days prior to the first dose of study drug treatment (false-positive results can be excluded by the investigator from enrollment after pregnancy), agree to use effective contraceptive measures such as double barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc., throughout the treatment period and for 180 days after the last dose of study drug. Female patients who are able to breastfeed are not allowed to breastfeed; 3) Male subject, has had a vas deferens removed or agrees to use effective contraception throughout the treatment period and for 180 days from the last dose of study drug
Exclusion criteria
Exclusion criteria: (1) Those with a history of chronic heart failure; (2) Those who have a history of acute myocardial infarction in the past; (3) Acute myocardial infarction accompanied by mechanical complications such as free wall rupture, ventricular septal perforation, papillary muscle or chordae tendinae rupture; (4) Patients with hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic right ventricular dysplasia, stress cardiomyopathy, chemotherapy-induced cardiomyopathy, perinatal cardiomyopathy, infiltrative cardiomyopathy and other diseases; (5) Patients with right heart failure caused by cor pulmonale or other causes unrelated to left ventricular dysfunction; (6) Patients with pericardial coarctation or active pericarditis; (7) Cerebrovascular accident, transient ischemic attack, major cardiac or carotid artery surgery (including cardiac and carotid intervention) within 6 months before screening; (8) Patients with acute respiratory distress syndrome; (9) Patients with hypertension who have systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg after active antihypertensive therapy; (10) persistent and/or symptomatic hypotension (systolic blood pressure 110 beats/min at screening. (15) Severe arrhythmia (sustained ventricular tachycardia or other conditions that the investigator believes need to be excluded) within 3 months before screening; (16) Presence of second-degree, type II, or third-degree atrioventricular block without pacemaker at screening; (17) Those with a clinical diagnosis of a large amount of pericardial effusion or pleural effusion, and the investigator assesses that it is clinically significant or requires intervention; (18) Chronic lung disease requiring continuous oxygen, oral hormone or bronchodilator medication or repeated hospitalization due to flare-ups within the previous 12 months, or severe lung disease of significant significance in the opinion of the investigator; (19) Those who have a history of malignant tumors (excluding clinically cured tumors) within 5 years before screening, and the investigator believes that they are not suitable for enrollment; (20) Diabetic ketoacidosis or lactic acidosis during the screening period; (21) Those who still have serum potassium 5.5 mmol/L after active treatment during the screening period; (22) abnormal liver function due to non-cardiac causes, defined as serum levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) measured during hospitalization above the upper limit of normal (ULN) of 3× or presence of a history of cirrhosis with evidence of portal hypertension (e.g., varicose veins); (23) Presence of severe renal impairment during the screening period, defined as creatinine clearance <30 mL/min (according to the Cockcroft-Gault formula); (24) Hemoglobin < 60 g/L during the screening period; (2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in Terminal Pro-Brain Natriuretic Peptide; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change from baseline in Terminal Pro-Brain Natriuretic Peptide;Change from baseline in Terminal Pro-Brain Natriuretic Peptide;Percent change from baseline in Left Ventricular Ejection Fraction;Percent change from baseline in Left Ventricular End-Diastolic Diameter;Percent change from baseline in Left Ventricular End-Systolic Dimension;Percent change from baseline in myocardial markers;Incidence of death (all-cause or cardiovascular) and time to death;Incidence and timing of heart failure exacerbations (events requiring hospitalization or emergency treatment due to heart failure exacerbations).;Adverse events and serious adverse events;Vital signs;physical examination;Laboratory tests;electrocardiogram;Change in trough concentration of Nicotinamide Adenine Dinucleotide over time;Change in trough concentration of Nicotinamide over time; | — |
Countries
China
Contacts
Public ContactJunbo Ge
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed