pediatric heart failure
Conditions
Interventions
Intervention group:Addition of ivabradine to conventional therapy
Sponsors
Children's Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
0.5 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Aged 6 months -18 years; 2. NYHA or modified Ross classification II-IV (modified Ross classification for 3 years old) and stable time >=4 weeks; 3. Impaired ventricular systolic function (LVEF = 105 bpm, 1-3 years old (excluding 1 and 3 years old) >= 95 bpm, 3-5 years old >= 75 bpm (excluding 5 years old), 5-18 years old >= 70 bpm; 5. The children and their guardians agreed to participate in this study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Participated in other clinical trials within 4 weeks before the start of this study; 2. Contraindications to ivabradine: allergic to ivabradine active ingredients or any excipients, unstable or acute heart failure, cardiogenic shock, severe hypotension (6-12 months systolic blood pressure = 10 years old < 90 mmHg), bradycardia (lower than the lowest level of resting heart rate in this age group), severe hepatic insufficiency, sick sinus syndrome, sinoatrial block, pacemaker-dependent patients, II, III degree atrioventricular block, etc., congenital QT syndrome; 3. The currently used drugs are incompatible with ivabradine, such as strong cytochrome P450 3A4 inhibitors, or moderate CYP3A4 inhibitors verapamil and diltiazem that have the effect of reducing heart rate; 4. Heart transplant recipients or listed heart transplant plans; 5. Malignant diseases, such as leukemia, malignant tumors, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| heart rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Echocardiography;routine blood test;liver and renal function;B-type natriuretic peptide;ECG;markers of myocardial injury; | — |
Countries
China
Contacts
Public ContactSun Huichao
Children's Hospital of Chongqing Medical University
Outcome results
None listed