UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034279 |
|---|---|
| Receipt number | R000039077 |
| Scientific Title | Low invasive monitoring in patients with cardiac diseases 2 |
| Date of disclosure of the study information | 2018/09/27 |
| Last modified on | 2024/03/31 10:50:19 |
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Basic information
Public title
Low invasive monitoring in patients with cardiac diseases 2
Acronym
Low invasive monitoring in patients with cardiac diseases 2
Scientific Title
Low invasive monitoring in patients with cardiac diseases 2
Scientific Title:Acronym
Low invasive monitoring in patients with cardiac diseases 2
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficiency of low invasive monitoring in patients with cardiac diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cardiac death and readmission for heart failure
Key secondary outcomes
cardiac death, readmission for heart failure, all-cause death, biomarkers, Oxygen saturation, physical signs
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients admitted with congestive heart faiure
Key exclusion criteria
no consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka Red Cross Hospital
Division name
Cardiovascular center
Zip code
5438555
Address
Osaka-shi Tennouji-ku Fudegasaki-cho 5-30
TEL
0667745111
nagao@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | K |
| Middle name | |
| Last name | Nozu |
Organization
Osaka Red Cross Hospital
Division name
the general affairs department
Zip code
5438555
Address
Osaka-shi Tennouji-ku Fudegasaki-cho 5-30
TEL
09096964773
Homepage URL
soumudaiichi@osaka-med.jrc.or.jp
Sponsor or person
Institute
Osaka Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Osaka Cancer Society
IRB Contact (For public release)
Organization
Osaka Red Cross Hospital
Address
TENNOUJI-KU FUDEGASAKI 5-30
Tel
0667745111
soumudaiichi@osaka-med.jrc.or.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 | 09 | Month | 27 | Day |
Related information
URL releasing protocol
https://academic.oup.com/ehjacc/article/11/5/407/6577227?login=true
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/ehjacc/article/11/5/407/6577227?login=true
Number of participants that the trial has enrolled
239
Results
Peripheral venous pressure (PVP) at discharge correlated with peripheral edema, jugular venous pressure, and inferior vena cava diameter. PVP correlated with the risk of 1 year incidence of the primary outcome measure (cardiovascular death or HF hospitalization). When added onto the Meta Analysis Global Group in Chronic HF risk score, PVP significantly increased the area under the receiver operating characteristic curve for predicting the outcome.
Results date posted
| 2024 | Year | 03 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study cohort included 239 patients who were hospitalized for acute HF
between September 2018 and March 2020 at Osaka Red Cross Hospital.
Participant flow
Acute HF was defined based on the following typical signs and symptoms of HF that required unplanned admission and HF-specific intravenous drug therapy including diuretics, inotropes and vasodilators, within 24 h of hospital admission: paroxysmal nocturnal dyspnea, orthopnea, dyspnea on exertion, rales, ankle edema, neck-vein distention, pleural effusion, and pulmonary edema 14. For patients with repeated HF hospitalization during the study
period, only the first hospitalization for HF was selected as an index hospitalization.According to the prespecified study protocol, we excluded patients if they had known active neoplasia, active hepatitis or liver cirrhosis, or severe renal dysfunction (creatinine >3 mg/dL or under hemodialysis).
Adverse events
none
Outcome measures
The prespecified primary outcome measure was a composite of cardiovascular death or
HF hospitalization throughout the 1-year follow-up. Secondary outcome measures were
defined as the individual component of the primary outcome measure, all-cause death and
any unplanned hospitalization throughout the 1-year follow-up. Follow-up began on the
day of discharge.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the relationships between the parameters obtained from low invasive monitoring and prognosis, biomarkers and physical signs
Management information
Registered date
| 2018 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039077
