UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014675
Receipt number 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 16:32:35

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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 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)



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

Value
https://center6.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