UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038225 |
|---|---|
| Receipt number | R000043575 |
| Scientific Title | IVA-PEF |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2022/10/13 09:35:10 |
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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
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
tanakah@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
16
Results
Primary end point
No significant change was observed in E/e 3 months after administration of 5 mg/day of ivabradine from 12.1 +/- 4.4 at baseline to 13.6 +/- 4.1 (p=0.16).
Secondary end point
No significant changes were
observed in BNP from 30.1 (9.2-85.0) pg/mL to 21.1 (11.7-154.2) pg/mL (p = 0.89) or LAVI from 38.7 +/- 17.5 mL/m2 to 44.0 +/- 17.1 mL/m2 (p=0.34). However, GLS significantly improved from 17.1 +/- 3.5% to 18.6 +/- 3.6% 3 months after administration of 5 mg/day of ivabradine (p=0.01).
Results date posted
| 2022 | Year | 10 | Month | 13 | Day |
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
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 08 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 08 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 08 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 19 | Day |
Other
Other related information
The manuscript of this study has been accepted to Circulation Reports on September 3, 2022.
Management information
Registered date
| 2019 | Year | 10 | Month | 07 | Day |
Last modified on
| 2022 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043575
