UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of preload reserve in patients with heart failure with preserved ejection fraction using leg positive pressure maneuver
Acronym	Assessment of preload reserve for patients with heart failure with preserved ejection fraction
Scientific Title	Assessment of preload reserve in patients with heart failure with preserved ejection fraction using leg positive pressure maneuver
Scientific Title:Acronym	Assessment of preload reserve for patients with heart failure with preserved ejection fraction
Region	Japan

Condition
Condition	chronic heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the mechanism of hemodynamic decompensation for patients with heart failure with preserved ejection fraction by studying preload reserve
Basic objectives2	Others
Basic objectives -Others	To contribute to the understanding of the mechanism of heart failure in patients with elderly
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	change in forward stroke volume and ventricular filling pressure during leg positive pressure maneuver
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)control subjects are defined as who don't have any heart disease (2)heart failure patients are defined as who are admitted with hospital due to heart failure (3)age between 20 to 90 (4)gender is unmentioned (5)patients who agree to participate in this trial (6)hemodynamically stable patients under standard heart failure therapy (7)ejection fraction >50%
Key exclusion criteria	(1)hypotension (BP<90/50mmHg) or severe hypertension (BP>160/90mmHg) (2)acute organ damage other than heart within 3 months (3)patients with NYHA functional class IV (4)patients with severe renal or liver disease (5)pregnant woman (6)the patients with, or the history of deep venous thrombosis (7)those who have active trauma at the lower limbs (8)valvular heart disease more than moderate (9)atrial fibrillation
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Kensuke Middle name Last name Matsumoto
Organization	Kobe University Graduate School of Medicine
Division name	Department of Internal Medicine Division of Cardiovascular Medicine
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 Graduate School of Medicine
Division name	Department of Internal Medicine Division of Cardiovascular Medicine
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
Institute	Kobe University Graduate School of Medicine Department of Internal Medicine Division of Cardiovascular Medicine
Institute
Department

Funding Source
Organization	Kobe University Graduate School of Medicine Department of Internal Medicine Division of Cardiovascular Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokushima university hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
Tel	078-382-6667
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	2018 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Main results already published
Date of protocol fixation	2018 Year 06 Month 20 Day
Date of IRB	2019 Year 02 Month 20 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2022 Year 02 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational study

Management information
Registered date	2018 Year 06 Month 21 Day
Last modified on	2020 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037732