Cyanotic congenital heart disease
Conditions
Interventions
control group:placebo
experimental group:Trimetazidine hydrochloride tablets
Sponsors
Shanghai Children’s Medical Center, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Cyanotic congenital heart disease was diagnosed; (2) Age > 18 years; (3) LVEF value measured by MRI =55%; (4) Hypoxia: oxygen saturation in the resting state is less than 90% (oxygen saturation measurement method: the fingerhold-type photoelectric sensor is used to measure the average value for three times in the resting state, with an interval of more than 5 minutes for each measurement); (5) The regimen of taking other cardiovascular drugs was stable for 4 weeks or more.
Exclusion criteria
Exclusion criteria: (1) Liver dysfunction: ALT > 2 times the upper limit of normal; (2) Renal insufficiency: serum creatinine =2.2mg/dl (194.5µmol/L); (3) Patients with pacemakers are not suitable for MRI examination; (4) suffering from diabetes, hyperthyroidism and anemia; (5) Suffering from Parkinson's disease, Parkinson's syndrome, tremor, restless legs syndrome, etc.; (6) suffering from respiratory diseases that affect gas exchange: bronchiectasis, COPD, tuberculosis, idiopathic pulmonary fibrosis, etc.; (7) Other heart diseases: coronary artery lesions, history of myocardial infarction, hypertrophic cardiomyopathy, idiopathic dilated cardiomyopathy, severe arrhythmia, etc; (8) Malignant tumors and other systemic diseases; (9) motor nervous system diseases that restrict activity; (10) allergic to trimetazidine or any excipients thereof.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left Ventricular Ejection Fractions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of cardiac events;NYHA classification;Oxygen saturation;Trimetazidine serum concentration;NT-proBNP;6 minute walking distance;LVD-36 questionnaire score; | — |
Countries
China
Contacts
Public ContactHao Zhang
Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine
Outcome results
None listed