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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025808


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name