An observational study of chronic heart failure patients receiving ivabradine

Not Applicable

Completed

• Conditions: Chronic heart failure; Circulatory System

• Registration Number: ISRCTN11703380
• Lead Sponsor: Servier (Tianjin) Pharmaceutical Co., Ltd

Brief Summary

2021 Interim results article in https://pubmed.ncbi.nlm.nih.gov/34878632/ (added 09/12/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-08
• Study Completion: 2021-06-30
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1003

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Measured at the 1-month and 6-month visit:<br>1. Heart failure symptoms, measured based on the inquisition and physical examination carried out by cardiologists<br>2. Left ventricular function, measured by echocardiogram<br>3. Heart failure biomarker (BNP and/or NT-proBNP), assessed with a routine laboratory test<br>4. Quality of life, assessed by KCCQ questionnaire<br>5. Safety and tolerability of Corlentor®, measured through monitoring adverse drug reactions and changes of laboratory indicators after administration of the drug