UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of the prognostic significance of the leg positive pressure stress echocardiography for patients with chronic heart failure
Title of the study (Brief title)	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	Kensuke Matsumoto
Organization	Kobe university hospital
Division name	Division of cardiology
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	Kensuke Matsumoto
Organization	Kobe university hospital
Division name	Division of cardiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000017067