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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name