Condition category
Circulatory System
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Plain English Summary

Background and study aims
Heart failure means that the heart has become too weak or stiff and is unable to pump blood around the body. The annual mortality (death) rate of heart failure patients is over 20% despite receiving treatment. Higher heart rate is a risk factor for poor outcome, but heart rate reduction is often insufficient in such patients. The drug ivabradine (Corlentor®) improves heart function as well as long-term survival in chronic heart failure patients with reduced left ventricular ejection fraction (i.e. the amount of blood pumped out of the heart) through specifically heart rate reduction, and is recommended in the heart failure treatment guidelines of Europe, America and China. Since Corlentor® was just approved by Chinese food and drug administration (CFDA) in April 2015, more clinical information needs to be collected during practice in China. The aim of this study is to assess how well Corlentor® works and its safety in Chinese heart failure patients.

Who can participate?
Patients aged over 18 with chronic heart failure and reduced left ventricular ejection fraction whose resting heart rate is 75 beats per minute or over, and who have been prescribed Corlentor® before entering the study

What does the study involve?
All patients are asked to come to follow-up visits after four weeks and then after another five months. During these visits a routine practice investigation is carried out. A quality of life questionnaire is completed and the safety and tolerability of Corlentor® is measured and evaluated during the follow-up visits. The dosage of Corlentor® can be adapted or even discontinued if needed during the follow-up period according to heart rate reduction, but the follow-up visits continue as scheduled regardless of whether the Corlentor® is taken or not.

What are the possible benefits and risks of participating?
Corlentor® may relieve heart failure symptoms, improve heart function and quality of life, and reduce the re-hospitalization and/or death rate. Close follow-up by investigators during the study may also provide additional benefit to the participants. Corlentor® has been used worldwide since 2005 and was approved in China in 2015, and the possible side effects include phosphenes (visual disturbances) and bradycardia (slow heart rate).

Where is the study run from?
About 80 hospitals all over China, with Zhongshang Hospital Fudan University as the leading site.

When is the study starting and how long is it expected to run for?
December 2016 to December 2018

Who is funding the study?
Servier (Tianjin) Pharmaceutical Co., Ltd (China)

Who is the main contact?
Dr Xiaoxing Zhang

Trial website

Contact information



Primary contact

Dr Xiaoxing Zhang


Contact details

6th Floor
West Building
World Financial Center
No. 1
East 3rd Ring Middle Road
Chaoyang District

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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



Study hypothesis

To assess the efficacy and safety of Corlentor®(ivabradine) in Chinese chronic heart failure patients.

Ethics approval

Ethics committee of Zhongshan Hospital Fudan University, 12/09/2016, ref: B2016-118

Study design

Prospective multicentre single-arm observational study

Primary study design


Secondary study design

Single-arm study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Chronic heart failure


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 information during the follow-up period (1-month and 6-month visits). The study drug dose is adjusted or discontinued based on the doctor’s judgement during the follow-up period. Follow-up continues until the 6-month visit regardless of the study drug use.

The study drug (Corlentor®) should be used following the description of the label. 5 mg bid is the recommended starting dose, but the starting dose can be changed based on the patient’s situation and adjusted during the follow-up period. It is recommended on the label that a 2.5 mg bid starting dose should be considered in patients aged over 75, with dose adjustment based on the patient's heart rate (because the direct efficacy of Corlentor® is heart rate reduction), and the maximum dose should not exceed 7.5 mg bid during long-term use.

Intervention type



Not Applicable

Drug names

Corlentor® (Ivabradine)

Primary outcome measures

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

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

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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 β-blockers) for heart failure, or are intolerable or contraindicated to β-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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Zhongshang Hospital Fudan University (leading site)

Trial participating centre

80 sites in China

Sponsor information


Servier (Tianjin) Pharmaceutical Co., Ltd

Sponsor details

6th Floor
West Building
World Financial Center
No. 1
East 3rd Ring Middle Road
Chaoyang District

Sponsor type




Funder type


Funder name

Servier (Tianjin) Pharmaceutical Co., Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

To be confirmed at a later date

IPD sharing statement:
The datasets generated and/or analysed during the current study are available from Prof. Junbo Ge ( on reasonable request.

Intention to publish date


Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

31/10/2017: Internal review.