UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038678
Receipt number R000043918
Scientific Title Left atrial function and right ventricular-to-pulmonary circulation coupling during exercise in left heart disease
Date of disclosure of the study information 2019/11/26
Last modified on 2023/11/28 15:17:28

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Basic information

Public title

Left atrial function and right ventricular-to-pulmonary circulation coupling during exercise in left heart disease

Acronym

Left atrial function and right ventricular-to-pulmonary circulation coupling during exercise in left heart disease

Scientific Title

Left atrial function and right ventricular-to-pulmonary circulation coupling during exercise in left heart disease

Scientific Title:Acronym

Left atrial function and right ventricular-to-pulmonary circulation coupling during exercise in left heart disease

Region

Japan


Condition

Condition

left heart disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate prognostic impact of LA function during exercise in left heart disease.

Basic objectives2

Others

Basic objectives -Others

To investigate the link between left atrial function and right ventricular-to-pulmonary circulation coupling during exercise in left heart disease.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

hospitalization for HF/mortality

Key secondary outcomes

association between left atrial function and right ventricular-to-pulmonary circulation coupling during exercise.


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 with left heart disease
2) Over 20 years old
3) Patients without mitral valve replacement
4) Patients without adult congenital heart disease
5) Patients without active myocardial ischemia
6) Patients without hypertrophic obstructive cardiomyopathy
7) Patients with agreement for the study

Key exclusion criteria

1) Patients with a prognosis of less than 12 months due to non-cardiac disease
2) Contraindication to exercise stress testing
3) Patients with poor echocardiographic image quality
4) Patients who are determined to be inappropriate for inclusion in the study by the principal investigator/shareholder

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Tadafumi
Middle name
Last name Sugimoto

Organization

Mie University Hospital

Division name

Department of Clinical Laboratory

Zip code

514-8507

Address

2-174 Edobashi, Tsu

TEL

059-232-1111

Email

t_sugimoto_japan@hotmail.com


Public contact

Name of contact person

1st name Tadafumi
Middle name
Last name Sugimoto

Organization

Mie University Hospital

Division name

Department of Clinical Laboratory

Zip code

514-8507

Address

2-174 Edobashi, Tsu

TEL

059-232-1111

Homepage URL


Email

t_sugimoto_japan@hotmail.com


Sponsor or person

Institute

Mie University Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

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

the Clinical Research Ethics Review Committee of Mie University Hospital

Address

2-174 Edobashi, Tsu

Tel

059-232-1111

Email

kk-sien@mo.medic.mie-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 26 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

Terminated

Date of protocol fixation

2019 Year 06 Month 17 Day

Date of IRB

2019 Year 11 Month 05 Day

Anticipated trial start date

2019 Year 11 Month 27 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Single center prospective study to investigate the prognostic impact of left atrial function during exercise in left heart disease. The composite end point of hospitalization for heart failure/ all-cause mortality in 2 yearswas used as the primary outcome.


Management information

Registered date

2019 Year 11 Month 25 Day

Last modified on

2023 Year 11 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043918


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name