UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022391 |
|---|---|
| Receipt number | R000025808 |
| Scientific Title | Assessment of the prognostic significance of the leg positive pressure stress echocardiography for patients with aortic valve stenosis |
| Date of disclosure of the study information | 2016/05/20 |
| Last modified on | 2019/12/10 00:14:13 |
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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
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
kenmatsu@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of cardiology, Kobe university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025808
