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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038225
Receipt No. R000043575
Scientific Title IVA-PEF
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/07

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Basic information
Public title Effect of ivabradine on left ventricular diastolic function in patients with heart failure with preserved ejection fraction
Acronym IVA-PEF
Scientific Title IVA-PEF
Scientific Title:Acronym IVA-PEF
Region
Japan

Condition
Condition Heart failure with preserved ejection fraction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of ivabradine on left ventricular diastolic function in heart failure patients with preserved ejection fraction
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A change in E/e' between baseline and 6 months after the start of administration
of ivabradine
Key secondary outcomes A change in BNP (NT-proBNP) and left atrial volume index between baseline and 6 months after the start of administration
of ivabradine

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of ivabradine
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients with heart failure with preserved ejection fraction including Stage A heart failure
(2) Patients with resting heart rate greater than equal to 75bpm
(3) NYHA functional classification and receiving cardio-protective drugs such as ACE inhibitors, ARBs, or beta-blockers has been stable for 4 weeks from enrollment
Key exclusion criteria (1) Patients with atrial fibrillation
(2) Patients with sick sinus syndrome, interatrial block, third-degree atrioventricular block
(3) Patients with hypotension (systolic blood pressure less than 90mmHg or diastolic blood pressure less than 50mmHg)
(4) Patients with severe liver disease (Child-Pugh C)
(4) Patients with hyperkalemia or serum potassium level>5.0mEq/L at enrollment
(5) Patients erceiving Ritonavir pharmacokinetics, Josamycin, Itraconazole, Clarithromycin, Cobicistat, Indinavir, Voriconazole, Nelfinavir mesilate, Saquinavir, Telaprevir, Verapamil hydrochloride,Diltiazem hydrochloride
(6) Pregnant women, lactating woman or women who wish to a pregnancy
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Hidekazu
Middle name
Last name Tanaka
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code 650-0017
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-5846
Email tanakah@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Hidekazu
Middle name
Last name Tanaka
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code 650-0017
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-5846
Homepage URL
Email tanakah@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kobe University Hospital Clinical & Translational Reserch Center
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe
Tel 078-382-6669
Email cerb@med.kobe-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2022 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 07 Day
Last modified on
2019 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043575

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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