UMIN-CTR Clinical Trial

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
Institute	Hokkaido University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044280