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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014675
Receipt No. R000017067
Scientific Title Assessment of the prognostic significance of the leg positive pressure stress echocardiography for patients with chronic heart failure
Date of disclosure of the study information 2014/09/01
Last modified on 2018/07/31

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

Condition
Condition Patients with chronic heart failure
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, and sudden cardiac death
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 right ventricular and left atrial function from baseline using speckle-tracking echocardiography

Base
Study type

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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1 Patients between 20 and 80 years old
2 Out patients and inpatients with chronic heart failure
3Patients 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 symptom of heart failure, or those with previous admission due to heart failure.
6 Patients with written informed consent.
7 Patients whose medication will not significantly change during 2 years study period.
Key exclusion criteria 1) Patients with significant hypotension (<90/50mmHg) or uncontrolled hypertension (>160/90mmHg).
2) Patients with acute illness within 3 months.
3) Patients with life-threatening ventricular arrhythmia.
4) Patients with NYHA 4 heart failure.
5) Patients with severe hepatic diseases including fulminant hepatitis, liver cirrhosis, or hepatic tumor.
6) Patients with severe renal diseased or those with hemodialysis.
7) Patients who experienced malignancy within 5 years.
8) Pregnant women.
9) Patients with venous thrombosis or the history of venous thrombosis.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kensuke Matsumoto
Organization Kobe university hospital
Division name Division of cardiology
Zip code
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
Middle name
Last name Kensuke Matsumoto
Organization Kobe university hospital
Division name Division of cardiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 09 Month 01 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
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
2014 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 28 Day
Last modified on
2018 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017067

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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