UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039001
Receipt number R000044280
Scientific Title The relationship between cardiac function and hemodynamic change during exercise and prognosis in patients with heart failure
Date of disclosure of the study information 2019/12/27
Last modified on 2020/01/06 16:59:59

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Basic information

Public title

The relationship between cardiac function and hemodynamic change during exercise and prognosis in patients with heart failure

Acronym

The relationship between cardiac function and hemodynamic change during exercise and prognosis in patients with heart failure

Scientific Title

The relationship between cardiac function and hemodynamic change during exercise and prognosis in patients with heart failure

Scientific Title:Acronym

The relationship between cardiac function and hemodynamic change during exercise and prognosis in patients with heart failure

Region

Japan


Condition

Condition

Heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the relationship between cardiac function, hemodynamic changes during exercise and prognosis in patients with heart failure.

Basic objectives2

Others

Basic objectives -Others

N/A

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

All cause death and rehospitalization due to worsening heart failure

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

1. Patients aged more than 20 years old
2. Patients who can undergo exercise right heart catheter examination
3. All patients receive from physicians the information necessary to give informed consent in writing

Key exclusion criteria

Patients judged inappropriate for this study

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Toshiyuki
Middle name
Last name Nagai

Organization

Faculty of Medicine and Graduate School of Medicine, Hokkaido University

Division name

Department of Cardiovascular Medicine

Zip code

060-8638

Address

Kita-15, Nishi-7, Kita-ku, Sapporo, Japan

TEL

011-706-6973

Email

tnagai@huhp.hokudai.ac.jp


Public contact

Name of contact person

1st name Yuta
Middle name
Last name Kobayashi

Organization

Faculty of Medicine and Graduate School of Medicine, Hokkaido University

Division name

Department of Cardiovascular Medicine

Zip code

060-8638

Address

Kita-15, Nishi-7, Kita-ku, Sapporo, Japan

TEL

011-706-6973

Homepage URL


Email

kobayashiyuta1989@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency
Fukuda Foundation for Medical Technology research grant
Hokkaido Heart Association Grant for Research

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hokkaido University Hospital Division of Clinical Research Administration

Address

Kita-14, Nishi-5, Kita-ku, Sapporo, Japan

Tel

011-706-7636

Email

crjimu@huhp.hokudai.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

北海道大学病院(北海道)


Other administrative information

Date of disclosure of the study information

2019 Year 12 Month 27 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

Open public recruiting

Date of protocol fixation

2019 Year 10 Month 11 Day

Date of IRB

2019 Year 10 Month 11 Day

Anticipated trial start date

2019 Year 11 Month 01 Day

Last follow-up date

2028 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We will prospectively perform this exploratory observational research.
We will investigate the relationship between cardiac function, hemodynamic changes measured by exercise right heart catheter examination and the following information.
1. Physical examination
2. Laboratory data
3. Physiological function testing
4. Imaging tests such as echocardiogram
5. Cardiopulmonary exercise test
6. The composite of rehospitalization due to heart failure and all cause death
7. Existing indicators of heart failure severeity


Management information

Registered date

2019 Year 12 Month 25 Day

Last modified on

2020 Year 01 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044280


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name