UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003640 |
|---|---|
| Receipt number | R000004071 |
| Scientific Title | Clinical Effeicacy of Intrathoracic Impedance Monitoring in Patients with Left Ventricular Systolic Dysfunction |
| Date of disclosure of the study information | 2010/05/19 |
| Last modified on | 2010/05/19 13:44:45 |
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Basic information
Public title
Clinical Effeicacy of Intrathoracic Impedance Monitoring in Patients with Left Ventricular Systolic Dysfunction
Acronym
Clinical Effeicacy of Intrathoracic Impedance Monitoring in Patients with Left Ventricular Systolic Dysfunction.
Scientific Title
Clinical Effeicacy of Intrathoracic Impedance Monitoring in Patients with Left Ventricular Systolic Dysfunction
Scientific Title:Acronym
Clinical Effeicacy of Intrathoracic Impedance Monitoring in Patients with Left Ventricular Systolic Dysfunction.
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between clinical heart failure event and fluid index.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
positive predict value
Key secondary outcomes
1. sensitivity, specificity and false positive of fluid index
2. optimal fluid index value
3. duration between alert and heart failure event
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.patients with left ventricular ejection fraction <35%
2. successful implantation of ICD or CRTD
3. Class I or II ICD indication
Key exclusion criteria
chronic renal failure (Serum-Cre > 3.0mg/dl), Severe anemia (Hb < 10g/dl), Chronic obstructive pulmonary disease, pocket infection or severe hematoma after implantation,severe pleural effusion, prior device infection, prior acute myocardial infarction within 6 months, pregnancy and breastfeeding, cardiac transplant, life expectancy <1 year
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimitsu Soga |
Organization
Kokur Memorial Hospital
Division name
department of Cardiology
Zip code
Address
1-1 Kifune-machi Kokurakita-ku Kitakyushu
TEL
093-921-2231
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimitsu Soga |
Organization
Kokura Memorial Hospital
Division name
cardiology
Zip code
Address
TEL
Homepage URL
sogacchy@yahoo.co.jp
Sponsor or person
Institute
Kokura Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Kokur Memorial Hospital
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
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
| 2010 | Year | 05 | Month | 19 | 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
Completed
Date of protocol fixation
| 2007 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2010 | Year | 07 | Month | 01 | Day |
Other
Other related information
observation period: 12 months
clinical visit after implantation: 1, 3, 6 and 12 months to evaluate the presence of hear failure
Management information
Registered date
| 2010 | Year | 05 | Month | 19 | Day |
Last modified on
| 2010 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004071
