Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets （FIRST） (FIRST)

July 10, 2014 updated by: Jiangsu HengRui Medicine Co., Ltd.
Ivabradine acts by inhibiting the ionic If current that modulates the pacemaker activity of sinoatrial node cells. The aim of present study is to evaluate the efficacy and safety of IvabRadine hemisulfate Sustained-release Tablets versus placebo in patients with moderate to severe chronic systolic heart failure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
336

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Not yet recruiting
        • The military general hospitla of Beijing PLA
        • Contact:
          • Junxia Li
        • Sub-Investigator:
          • Junxia Li
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Suzhou University
        • Contact:
          • Yang Jiao
        • Sub-Investigator:
          • Yang Jiao
      • Yangzhou, Jiangsu, China, 225001
        • Not yet recruiting
        • Subei People's Hospital of Jiangsu province
        • Contact:
          • Xiang Gu
        • Sub-Investigator:
          • Xiang Gu
    • Jilin
      • Changchun, Jilin, China
        • Not yet recruiting
        • The First hospital of Jilin University
        • Contact:
          • Yu Zhang
        • Sub-Investigator:
          • Yu Zhang
    • Liaoning
      • Shenyang, Liaoning, China
        • Not yet recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
          • Shumei Ma
        • Sub-Investigator:
          • Shumei Ma
    • Shandong
      • Jinan, Shandong, China
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Sub-Investigator:
          • Ming Zhong
      • Jinan, Shandong, China
        • Not yet recruiting
        • The Second Hospital of Shandong University
        • Contact:
          • Qinghua Lu
        • Sub-Investigator:
          • Qinghu Lu
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • the Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
          • Jianan Wang, Doctor
        • Principal Investigator:
          • Jianan Wang, doctor
      • Hangzhou, Zhejiang, China, 310003
        • Not yet recruiting
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • Contact:
          • Xiaosheng Hu
        • Sub-Investigator:
          • Xiaosheng Hu
      • Hangzhou, Zhejiang, China, 310006
        • Not yet recruiting
        • Hangzhou First People's Hospital
        • Contact:
          • Yizhou Xu
        • Sub-Investigator:
          • Yizhou Xu
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Weijian Huang
        • Sub-Investigator:
          • Weijian Huang
      • Wenzhou, Zhejiang, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Jifei Tang
        • Sub-Investigator:
          • Jifei Tang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged from 18 to 75 years, males or females
  • Willing to provide written informed consent

  • NYHA Class II, III, or IV for≥4 weeks, in stable clinical condition for

    ≥4 weeks

  • Optimized and unchanged chronic heart failure medications and dosages for≥4 weeks
  • Sinus rhythm with resting heart rate≥70 b.p.m.
  • Left-ventricular systolic dysfunction, with ejection fraction≥40% documented within previous 1 month

Exclusion Criteria:

  • Unstable cardiovascular condition(for example, hospital admission for worsening heart failure)
  • Recent (<2 months) myocardial infarction or recent or scheduled coronary revascularization
  • Stroke or transient cerebral ischaemia within previous 4 weeks
  • Severe primary valvular disease
  • Scheduled surgery of valvular heart disease
  • Active myocarditis
  • Congenital heart diseases
  • peripartum cardiomyopathy
  • hyperthyroid heart disease
  • On list for cardiac transplantation
  • Cardiac resynchronization therapy started within previous 6 months
  • Pacemaker with atrial or ventricular pacing (except biventricular pacing)˃40% of the time, or with stimulation threshold at the atrial or ventricular level˃60 b.p.m.
  • Permanent atrial fibrillation or flutter
  • Sick sinus syndrome, sinoatrial block, second and third degree atrio-ventricular block
  • History of symptomatic or sustained (≥30 s) ventricular arrhythmia unless a cardioverter/defibrillator implanted
  • Cardioverter/defibrillator shock within previous 6 months
  • Family history or congenital long QT syndrome or treated with selected QT-prolonging products(except amiodarone)
  • Contraindication or intolerance to ivabradine or lactulose
  • Severe or uncontrolled hypertension (SBP≥180 mmHg or DBP≥110 mmHg)
  • known anaemia(Hb<100 g/L)
  • Known moderate or severe liver disease(ALT/AST˃3ULN), known severe renal disease(Cr˃2ULN)
  • Pregnant or lactating women and women planning to become pregnant
  • Use of an investigational drug within 30 days of enrollment
  • Has a history of psychological illness/condition that interferes with ability to understand or complete requirements of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IvabRadine hemisulfate Sustained-release Tablets
5-15mg qd
Drug: IvabRadine hemisulfate Sustained-release Tablets
Placebo Comparator: placebo
5-15mg qd
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change From Baseline in Left Ventricular End Systolic Volume Index by ultrasound cardiogram
Time Frame: baseline and week 32
baseline and week 32

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change From Baseline in Left Ventricular End Diastolic Volume Index and left ventricular ejection fraction(LVEF)
Time Frame: baseline and week 32
baseline and week 32
incidence of hospital admission for worsening heart failure、any cardiovascular hospital admission、 cardiovascular mortality、all-cause mortality
Time Frame: baseline and week 32
baseline and week 32
change from baseline in distance of 6-minute walking test
Time Frame: baseline and week 32
baseline and week 32
change from baseline in heart rate
Time Frame: baseline and week 32
baseline and week 32
change from baseline in scores of Kansas City Cardiomyopathy Questionnaire
Time Frame: baseline and week 32
baseline and week 32
change from baseline in NT-proBNP
Time Frame: baseline and week 32
baseline and week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jianan Wang, Doctor, Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LSQYFBLDHF2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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