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

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

336

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • 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

May 1, 2014

Primary Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 9, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 11, 2014

Study Record Updates

Last Update Posted (Estimate)

July 11, 2014

Last Update Submitted That Met QC Criteria

July 10, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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