Skip to content

An observational study of chronic heart failure patients receiving ivabradine

POSITIVE: POSt-authorization drug Intensive surveillance monitoring sTudy of IVabradine efficacy and safety in patients with chronic heart failurE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN11703380
Enrollment
3300
Registered
2016-11-08
Start date
2016-12-31
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic heart failure Circulatory System

Interventions

This study enrolls patients who have already been administered the study drug in line with the indication described on the label based on the doctor’s decision. After that, the investigator collects i

Sponsors

Servier (Tianjin) Pharmaceutical Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026