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

Chronic Systolic Heart Failure Clinical Trial

— FIRST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02188082
• Other study ID #: LSQYFBLDHF2013
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 9, 2014
• Last updated: July 10, 2014
• Start date: May 2014

Study information

• Verified date: May 2014
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Jianan Wang, doctor
• Phone: 0571-87315001
• Email: wang_jian_an[@]tom.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 336
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Systolic Heart Failure
• Heart Failure
• Heart Failure, Systolic

Intervention

Drug:
• IvabRadine hemisulfate Sustained-release Tablets

• placebo

Locations

Country	Name	City	State
China	The military general hospitla of Beijing PLA	Beijing	Beijing
China	the First Hospital of Jilin University	Changchun	Jilin
China	Hangzhou First People'S Hospital	Hangzhou	Zhejiang
China	The first affiliated hospital of zhejiang university school of medicine	Hangzhou	Zhejiang
China	The second affiliated hospital of zhejiang university school of medicine	Hangzhou	Zhejiang
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	the Second Hospital of Shandong University	Jinan	Shandong
China	shengjing hospital of China medical university	Shenyang	Liaoning
China	The second affiliated hospital of suzhou university	Suzhou	Jiangsu
China	The first affiliated hospital of wenzhou medical university	Wenzhou	Zhejiang
China	The second affiliated hospital of wenzhou medical university	Wenzhou	Zhejiang
China	Subei People's Hospital of Jiangsu province	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Left Ventricular End Systolic Volume Index by ultrasound cardiogram		baseline and week 32	No
Secondary	Change From Baseline in Left Ventricular End Diastolic Volume Index and left ventricular ejection fraction(LVEF)		baseline and week 32	No
Secondary	incidence of hospital admission for worsening heart failure?any cardiovascular hospital admission? cardiovascular mortality?all-cause mortality		baseline and week 32	Yes
Secondary	change from baseline in distance of 6-minute walking test		baseline and week 32	No
Secondary	change from baseline in heart rate		baseline and week 32	Yes
Secondary	change from baseline in scores of Kansas City Cardiomyopathy Questionnaire		baseline and week 32	Yes
Secondary	change from baseline in NT-proBNP		baseline and week 32	Yes