UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021032
Receipt number R000024273
Scientific Title The Clinical Significance of Pulse Wave velocity in Patients with Heart Failure with Preserved Ejection Fraction
Date of disclosure of the study information 2016/02/15
Last modified on 2016/02/15 16:52:57

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The Clinical Significance of Pulse Wave velocity in Patients with Heart Failure with Preserved Ejection Fraction

Acronym

Heart failure with preserved ejection fraction and PWV

Scientific Title

The Clinical Significance of Pulse Wave velocity in Patients with Heart Failure with Preserved Ejection Fraction

Scientific Title:Acronym

Heart failure with preserved ejection fraction and PWV

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 assess the relationship between PWV and other biomarker of heart failure in patient with heart failure with preserved ejection fraction and to investigate the prognostic involvement of PWV in the future cardiovascular events in patients with heart failure with preserved ejection fraction.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Composite endopoint of cardiovascular death, non-fatal myocardial infarction, unstable angina pectoris, non-fatal ischemic stroke, re-hospitalization for heart failure, or coronary revascularization

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with heart failure who were hospitalized in Kumamoto University Hospital

Key exclusion criteria

Do not meet diagnostic criteria for heart failure with preserved ejection fraction
Acute coronary syndrome
Active infection diseases
History of malignancy
End stage of chronic kidney diseases

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Seiji Hokimoto

Organization

Graduate School of Medical Sciences, Kumamoto University

Division name

Department of Cardiovascular Medicine

Zip code


Address

1-1-1 Honjo, Kumamoto City, JAPAN

TEL

+81963735175

Email

cvmhisho@kumamoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takanori Tokitsu

Organization

Graduate School of Medical Sciences, Kumamoto University

Division name

Department of Cardiovascular Medicine

Zip code


Address

1-1-1 Honjo, Kumamoto City, JAPAN

TEL

+81963735175

Homepage URL


Email

tokitsutakanori@gmail.com


Sponsor or person

Institute

Kumamoto University

Institute

Department

Personal name



Funding Source

Organization

Kumamoto University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2016 Year 02 Month 15 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

Completed

Date of protocol fixation

2008 Year 01 Month 07 Day

Date of IRB


Anticipated trial start date

2008 Year 01 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patients were followed every month at the outpatient clinic until December 2013 or until an endpoint occured.


Management information

Registered date

2016 Year 02 Month 15 Day

Last modified on

2016 Year 02 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024273


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name