UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033091 |
|---|---|
| Receipt number | R000037732 |
| Scientific Title | Assessment of preload reserve in patients with heart failure with preserved ejection fraction using leg positive pressure maneuver |
| Date of disclosure of the study information | 2018/06/30 |
| Last modified on | 2020/12/22 10:21:50 |
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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
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
kenmatsu@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine Department of Internal Medicine Division of Cardiovascular Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037732
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| Registered date | File name |
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