UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031774
Receipt number R000036272
Scientific Title predict of pulmonary circulation dynamics during exercise in patients with pulmonary hyper tension
Date of disclosure of the study information 2018/03/19
Last modified on 2022/09/20 05:45:50

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Basic information

Public title

predict of pulmonary circulation dynamics during exercise in patients with pulmonary hyper tension

Acronym

predict of pulmonary circulation dynamics during exercise in patients with pulmonary hyper tension

Scientific Title

predict of pulmonary circulation dynamics during exercise in patients with pulmonary hyper tension

Scientific Title:Acronym

predict of pulmonary circulation dynamics during exercise in patients with pulmonary hyper tension

Region

Japan


Condition

Condition

pulmonary hyper tension

Classification by specialty

Cardiology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine an index to predict rising pulmonary artery pressure during exercise in patients with pulmonary hypertension from the time of rest

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

mPAP-co slope during exercise

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

15 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Case in which right heart catheter examination with exercise load was performed and consent regarding use of the examination result was obtained

Key exclusion criteria

Case in which agreement on use of examination result was not obtained

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kazuki
Middle name
Last name Tobita

Organization

kyorin university hospital

Division name

Department of Rehabilitation

Zip code

1818611

Address

6-20-2 Shinkawa, Mitaka-city, Tokyo 181-8611, Japan

TEL

0422-47-5511

Email

skazuki1107@gmail.com


Public contact

Name of contact person

1st name Kazuki
Middle name
Last name Tobita

Organization

kyorin university hospital

Division name

Department of Rehabilitation

Zip code

1818611

Address

6-20-2 Shinkawa, Mitaka-city, Tokyo 181-8611, Japan

TEL

0422-47-5511

Homepage URL


Email

skazuki1107@gmail.com


Sponsor or person

Institute

kyorin university hospital department of rehabilitation

Institute

Department

Personal name



Funding Source

Organization

Japanese association of cardiac rihabilitation

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

no

Name of secondary funder(s)

no


IRB Contact (For public release)

Organization

kyorin university

Address

6-20-2, shinkawa, mitaka, tokyo, japan

Tel

0422-47-5514

Email

rec@ks.kyorin-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

杏林大学病院


Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 19 Day


Related information

URL releasing protocol

https://www.jstage.jst.go.jp/article/kyorinmed/52/4/52_167/_pdf

Publication of results

Unpublished


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/kyorinmed/52/4/52_167/_pdf

Number of participants that the trial has enrolled

30

Results

Increased pulmonary artery pressure during exercise was associated with increased ventilation at rest.

Results date posted

2022 Year 09 Month 20 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients in the exercise PH group (71 years:range 61-76) were significantly older than those in the non-exercise PH (46 years: range 37-55). We found no significant differences in each group for height, weight, PH background factors, and several cases receiving continuous intravenous injections of medical agents or type of oral medication. The mPAP-CO slope was 4.9 (range, 4.0-6.4) and 2.0 (range, 1.8-2.5) for the exercise PH and non-exercise PH groups, respectively.

Participant flow

Various evaluations during hospitalization for follow-up right heart catheterization purposes

Adverse events

none

Outcome measures

association between exercise-induced ph and resting parameters.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2018 Year 03 Month 16 Day

Date of IRB

2018 Year 03 Month 16 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2020 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Cross-sectional study


Management information

Registered date

2018 Year 03 Month 17 Day

Last modified on

2022 Year 09 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036272


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name