UMIN-CTR Clinical Trial

Basic information
Public title	Non-invasive assessment of preload reserve using the leg-positive pressure maneuver in patients with repaired tetralogy of Fallot
Acronym	The leg-positive pressure echocardiography for patients with repaired tetralogy of Fallot
Scientific Title	Non-invasive assessment of preload reserve using the leg-positive pressure maneuver in patients with repaired tetralogy of Fallot
Scientific Title:Acronym	The leg-positive pressure echocardiography for patients with repaired tetralogy of Fallot
Region	Japan

Condition
Condition	Tetralogy of Fallot
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to investigate the preload reserve of RV function and reveal its determining factor in patients with repaired TOF using LPP stress echocardiography.
Basic objectives2	Others
Basic objectives -Others	Hemodynamics
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	RV function and forward stroke volume at baseline and during LPP stress.
Key secondary outcomes	Standerd functional assessment, ventricular interaction between RV and left ventricle,left ventriclar diastolic dysfunction and BNP at baseline and during LPP stress.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	at rest and stress using the leg-positive pressure maneuver
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	repaired tetralogy of Fallot
Key exclusion criteria	(1) RV end-diastolic volume index exceeds 170 mL/m2 and/or RV end-systolic volume index exceeds 85 mL/m2 with severe PR (2) open-heart surgery within 6 months; (3) unstable heart failure; (4) unable to undergo LPP stress; (5) arrhythmia such as atrial fibrillation, second degree and third degree atrioventricular block and VVI pacing after pacemaker implantation; (6) orthopedic traumatic disease or active skin lesions in the lower limbs.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kensuke Middle name Last name Matsumoto
Organization	Kobe University Hospital
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code	6500017
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL	0783825846
Email	kenmatsu@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Kensuke Middle name Last name Matsumoto
Organization	Kobe University Hospital
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code	6500017
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL	0783825846
Homepage URL
Email	kenmatsu@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Kobe University
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	Kobe University Hospital Clinical & Translational Research Center
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel	0783826669
Email	chiken@med.kobe-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 10 Month 24 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	44
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	2018 Year 07 Month 01 Day
Date of IRB	2018 Year 07 Month 01 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 23 Day
Last modified on	2019 Year 10 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043726