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

Primary Purpose

Chronic Systolic Heart Failure

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
IvabRadine hemisulfate Sustained-release Tablets
placebo
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Systolic Heart Failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The military general hospitla of Beijing PLA
  • The second affiliated hospital of suzhou university
  • Subei People's Hospital of Jiangsu province
  • the First Hospital of Jilin University
  • shengjing hospital of China medical university
  • Qilu Hospital of Shandong University
  • the Second Hospital of Shandong University
  • The first affiliated hospital of zhejiang university school of medicine
  • Hangzhou First People'S Hospital
  • The second affiliated hospital of zhejiang university school of medicineRecruiting
  • The first affiliated hospital of wenzhou medical university
  • The second affiliated hospital of wenzhou medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IvabRadine hemisulfate Sustained-release Tablets

placebo

Arm Description

5-15mg qd

5-15mg qd

Outcomes

Primary Outcome Measures

Change From Baseline in Left Ventricular End Systolic Volume Index by ultrasound cardiogram

Secondary Outcome Measures

Change From Baseline in Left Ventricular End Diastolic Volume Index and left ventricular ejection fraction(LVEF)
incidence of hospital admission for worsening heart failure、any cardiovascular hospital admission、 cardiovascular mortality、all-cause mortality
change from baseline in distance of 6-minute walking test
change from baseline in heart rate
change from baseline in scores of Kansas City Cardiomyopathy Questionnaire
change from baseline in NT-proBNP

Full Information

First Posted
July 9, 2014
Last Updated
July 10, 2014
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02188082
Brief Title
Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets （FIRST）
Acronym
FIRST
Official Title
Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets （FIRST）
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Systolic Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IvabRadine hemisulfate Sustained-release Tablets
Arm Type
Experimental
Arm Description
5-15mg qd
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
5-15mg qd
Intervention Type
Drug
Intervention Name(s)
IvabRadine hemisulfate Sustained-release Tablets
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Left Ventricular End Systolic Volume Index by ultrasound cardiogram
Time Frame
baseline and week 32
Secondary Outcome Measure Information:
Title
Change From Baseline in Left Ventricular End Diastolic Volume Index and left ventricular ejection fraction(LVEF)
Time Frame
baseline and week 32
Title
incidence of hospital admission for worsening heart failure、any cardiovascular hospital admission、 cardiovascular mortality、all-cause mortality
Time Frame
baseline and week 32
Title
change from baseline in distance of 6-minute walking test
Time Frame
baseline and week 32
Title
change from baseline in heart rate
Time Frame
baseline and week 32
Title
change from baseline in scores of Kansas City Cardiomyopathy Questionnaire
Time Frame
baseline and week 32
Title
change from baseline in NT-proBNP
Time Frame
baseline and week 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianan Wang, doctor
Phone
0571-87315001
Email
wang_jian_an@tom.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianan Wang, Doctor
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The military general hospitla of Beijing PLA
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junxia Li
First Name & Middle Initial & Last Name & Degree
Junxia Li
Facility Name
The second affiliated hospital of suzhou university
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Jiao
First Name & Middle Initial & Last Name & Degree
Yang Jiao
Facility Name
Subei People's Hospital of Jiangsu province
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Gu
First Name & Middle Initial & Last Name & Degree
Xiang Gu
Facility Name
the First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Zhang
First Name & Middle Initial & Last Name & Degree
Yu Zhang
Facility Name
shengjing hospital of China medical university
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shumei Ma
First Name & Middle Initial & Last Name & Degree
Shumei Ma
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Zhong
First Name & Middle Initial & Last Name & Degree
Ming Zhong
Facility Name
the Second Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinghua Lu
First Name & Middle Initial & Last Name & Degree
Qinghu Lu
Facility Name
The first affiliated hospital of zhejiang university school of medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaosheng Hu
First Name & Middle Initial & Last Name & Degree
Xiaosheng Hu
Facility Name
Hangzhou First People'S Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yizhou Xu
First Name & Middle Initial & Last Name & Degree
Yizhou Xu
Facility Name
The second affiliated hospital of zhejiang university school of medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianan Wang, doctor
First Name & Middle Initial & Last Name & Degree
Jianan Wang, doctor
Facility Name
The first affiliated hospital of wenzhou medical university
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weijian Huang
First Name & Middle Initial & Last Name & Degree
Weijian Huang
Facility Name
The second affiliated hospital of wenzhou medical university
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jifei Tang
First Name & Middle Initial & Last Name & Degree
Jifei Tang

12. IPD Sharing Statement

Citations:
PubMed Identifier
35926931
Citation
Ye F, Wang X, Wu S, Ma S, Zhang Y, Liu G, Liu K, Yang Z, Pang X, Xue L, Lu S, Zhong M, Li J, Yu H, Lou D, Cui D, Xie X, Wang J; FIRST Investigators. Sustained-Release Ivabradine Hemisulfate in Patients With Systolic Heart Failure. J Am Coll Cardiol. 2022 Aug 9;80(6):584-594. doi: 10.1016/j.jacc.2022.05.027.
Results Reference
derived

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

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