UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of the prognostic significance of the leg positive pressure stress echocardiography for patients with aortic valve stenosis
Acronym	Prognostic assessment using leg positive pressure stress echocardiography
Scientific Title	Assessment of the prognostic significance of the leg positive pressure stress echocardiography for patients with aortic valve stenosis
Scientific Title:Acronym	Prognostic assessment using leg positive pressure stress echocardiography
Region	Japan

Condition
Condition	Patients with aortic valve stenosis
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to assess the left ventricular preload reserve using leg positive pressure stress echocardiography, and to assess the relationship between left ventricular functional reserve and the patient's prognosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Combined endpoint of admission due to heart failure, death from heart failure, sudden cardiac death, and fatal ventricular arrhythmias.
Key secondary outcomes	1) Change in NYHA functional class from baseline. 2) Changes in left ventricular ejection fraction, left ventricular end-diastolic, and end-systolic volume from baseline. 3) changes in contractile reserve and diastorlic reserve from baseline. 4) Changes in right ventricular and left atrial function from baseline using speckle-tracking echocardiography.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Leg positive pressure stress echocardiography
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	95 years-old >=
Gender	Male and Female
Key inclusion criteria	1 Patients between 20 and 95 years old. 2 Out patients and inpatients with aortic valve stenosis. 3 Patients with hemodynamically stable condition with standard heart failure treatment including beta blocker, ACE inhibitor, ARB, and diuretics. 4 Patients who can tolerate 5 minutes of leg positive pressure stress echocardiography. 5 Patients with written informed consent. 6 patients whom judged to be able to survaive more than one year.
Key exclusion criteria	1) Patients with significant hypotension (<90/50mmHg) or uncontrolled hypertension (>170/90mmHg). 2) Patients with acute illness within 3 months. 3) Patients with NYHA 4 heart failure. 4) Patients with unstable angina pectoris or more than 75% (AHA craiteria)coronary artery stenosis. 5) patients with more than moderate valvular regurgitation. 6) Patients with severe hepatic diseases including fulminant hepatitis, liver cirrhosis, or hepatic tumor. 7) Patients with severe renal diseased or those with hemodialysis. 8) Patients who experienced malignancy within 5 years. 9) Pregnant women. 10) Patients with venous thrombosis or the history of venous thrombosis. 11) Patients with leg trauma and dermopathy or the history of those diseases.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Kensuke Middle name Last name Matsumoto
Organization	Kobe university hospital
Division name	Division of cardiology
Zip code	650-0017
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL	078-382-5846
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 cardiology
Zip code	650-0017
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL	078-382-5846
Homepage URL
Email	kenmatsu@med.kobe-u.ac.jp

Sponsor
Institute	Division of cardiology, Kobe university hospital
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan

IRB Contact (For public release)
Organization	Kobe vuniv.
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, 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	2016 Year 05 Month 20 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	80
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	Completed
Date of protocol fixation	2016 Year 08 Month 01 Day
Date of IRB	2016 Year 08 Month 17 Day
Anticipated trial start date	2016 Year 08 Month 17 Day
Last follow-up date	2017 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 05 Month 20 Day
Last modified on	2019 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025808