Chronic heart failure Circulatory System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female, outpatients or inpatients, over 18 (inclusive) years old 2. Sinus rhythm 3. Resting heart rate =75 bpm as measured by 12-lead ECG prior to enrollment 4. Chronic heart failure patients with systolic dysfunction (the left ventricular ejection fraction (LVEF) was = 40 % in the last 3 months) 5. Patients whose cardiac function classification according to the New York Heart Association (NYHA) standard are class 2-4 6. Patients who have received standard treatment (including ß-blockers) for heart failure, or are intolerable or contraindicated to ß-blockers 7. Patients who meet the indication of Corlentor® and are starting to receive Corlentor® treatment 8. Patients who have signed the informed consent forms
Exclusion criteria
Exclusion criteria: 1. Patients who have received the treatment with Corlentor® within 2 weeks 2. Recent (<1 month) occurrence of acute myocardial infarction 3. Acute heart failure and cardiogenic shock 4. Sick sinus syndrome or sino-atrial block 5. Third-degree atrioventricular block 6. Severe hypotension (<90/50 mmHg) 7. Severe liver dysfunction (Child-Pugh score =10) 8. End-stage renal failure (Plasma creatinine clearance <15 ml/min) 9. Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures 10. Patients unable to visit as scheduled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart rate change after Corlentor® administration, measured using office daytime resting heart rate (heart rate and rhythm from the 12-lead ECG will also be considered for double-confirm if available) at the 1-month and 6-month visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at the 1-month and 6-month visit: 1. Heart failure symptoms, measured based on the inquisition and physical examination carried out by cardiologists 2. Left ventricular function, measured by echocardiogram 3. Heart failure biomarker (BNP and/or NT-proBNP), assessed with a routine laboratory test 4. Quality of life, assessed by KCCQ questionnaire 5. Safety and tolerability of Corlentor®, measured through monitoring adverse drug reactions and changes of laboratory indicators after administration of the drug | — |
Countries
China