UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017021
Receipt number R000019742
Scientific Title Risk stratification based on the relative intensity of right and left ventricular function by the ratio of right and left sided atrio-ventricular annular systolic velocities in patients with heart failure
Date of disclosure of the study information 2015/04/06
Last modified on 2020/10/05 09:45:06

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Basic information

Public title

Risk stratification based on the relative intensity of right and left ventricular function by the ratio of right and left sided atrio-ventricular annular systolic velocities in patients with heart failure

Acronym

Prognostic significance of the relative intensity of right and left ventricular function in patients with heart failure

Scientific Title

Risk stratification based on the relative intensity of right and left ventricular function by the ratio of right and left sided atrio-ventricular annular systolic velocities in patients with heart failure

Scientific Title:Acronym

Prognostic significance of the relative intensity of right and left ventricular function in patients with heart failure

Region

Japan


Condition

Condition

Acute decompensated heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the prognostic significance of the ratio of right and left sided atrio-ventricular annular velocities (ST/SM) by tissue Dopplar imaging (TDI) in patients with acute decompensated heart failure

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Cardiac death
2. Re-admission due to worsening heart failure
3. Implantation of left ventricular assist device

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Admission due to acute decompensated heart failure

Key exclusion criteria

1. Acute coronary syndrome
2. History of valve replacement

Target sample size

375


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Yasuda

Organization

National Cerebral and Cardiovascular Center

Division name

Cardiovascular Medicine

Zip code


Address

5-7-1, Fujishiro-dai, Suita, Osaka

TEL

06-6833-5012

Email

yasuda.satoshi.hp@mail.ncvc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiyuki Nagai

Organization

National Cerebral and Cardiovascular Center

Division name

Cardiovascular Medicine

Zip code


Address

5-7-1, Fujishiro-dai, Suita, Osaka

TEL

06-6833-5012

Homepage URL


Email

nagai@ncvc.go.jp


Sponsor or person

Institute

National Cerebral and Cardiovascular Center

Institute

Department

Personal name



Funding Source

Organization

National Cerebral and Cardiovascular Center

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


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

2015 Year 04 Month 06 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

No longer recruiting

Date of protocol fixation

2015 Year 04 Month 02 Day

Date of IRB

2014 Year 12 Month 26 Day

Anticipated trial start date

2015 Year 05 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Not applicable


Management information

Registered date

2015 Year 04 Month 02 Day

Last modified on

2020 Year 10 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019742


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name