UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046951 |
|---|---|
| Receipt number | R000053573 |
| Scientific Title | Registry of contemporary medical management of chronic heart failure with non-reduced ejection fraction in Japan |
| Date of disclosure of the study information | 2022/02/20 |
| Last modified on | 2024/08/23 09:04:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Registry of contemporary medical management of chronic heart failure with non-reduced ejection fraction in Japan
Acronym
The PARACLETE study
Scientific Title
Registry of contemporary medical management of chronic heart failure with non-reduced ejection fraction in Japan
Scientific Title:Acronym
The PARACLETE study
Region
| Japan |
Condition
Condition
HF with non-reduced EF (HF non-rEF; LVEF higher than 40%)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain the treatment Patterns and evaluate the factors that influence long-term prognosis in patients with heart failure with non-reduced EF
Basic objectives2
Others
Basic objectives -Others
Prospective cohort study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Proportion of patients with HF non-rEF were changed at the enrollment, and categories of reasons for the changing prescription at enrollment
2.A composite of unexpected HF hospitalization and all-cause death in a 2-year follow up
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Older than 20 years old
2)Fully understand the research content and have indicated their intention to cooperate in the research in writing.
3)Medical regimen of heart failure-related treatment (both pharmacotherapy and non-pharmacotherapy) was not changed at least the last 8 weeks
4)LVEF of higher than 40% (not including 40%) and less than 50% with transthoracic echocardiography performed within the last 12 months.
5) LVEF of 50% or more with transthoracic echocardiography performed within the last 12 months and meet at least one of the following conditions A or B.
A: A history of HF hospitalization B: No history of HF hospitalization but meets either following a or b . (Values in parentheses are for patients with atrial fibrillation.)
a. [BNP level of 100 (200) pg/ml or more] or [NT-proBNP level of 400 (800) pg/ml or more]
b. [BNP level of 40 (80) pg/ml or more and less than 100 (200) pg/ml] or [NT-proBNP level of 125 (250) pg/ml or more and less than 400 (800) pg/ml], and meet at least one of following I to VI of echocardiographic criteria
I. Interventricular septum or posterior wall thickness: 11 mm or more
II. Left atrium diameter: 38 mm or more
III. Left atrium length: 50 mm or more
IV. Left atrium area: 20 cm2 or more
V. Left atrium volume: 55 ml or more VI. Left atrium volume index: 29 ml / m2 or more
Key exclusion criteria
1) Severe renal dysfunction such as the latest eGFR of less than 15 ml / min / 1.73 m2 or during dialysis
2) Changed their heart failure-related treatment (both pharmacotherapy and non-pharmacotherapy) within 8 weeks from registration
3) Require urgent hospitalization due to heart failure
4). Confirmed diagnosis of cardiac amyloidosis and dilated cardiomyopathy
5. Confirmed diagnosis of obstructive hypertrophic cardiomyopathy and hypertrophic cardiomyopathy with a family history
6. Recover EF who have been pointed out that LVEF is 40% or less in the past
7. Pulmonary arterial hypertension
8. Severe liver disease or lung disease
9. Cancer with a prognosis of less than 1 year
10. Staying in Long-Term Care Health Facility or hospice
11. Participating in some interventional study
Target sample size
4200
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Ueda |
Organization
Nara Medical University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
634-8522
Address
840 shijyo-cho, Kashihara-city,NARA
TEL
0744-22-3051
saitonaramed@gmail.com
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Ueda |
Organization
Nara Medical University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
634-8522
Address
840 shijyo-cho, Kashihara-city,NARA
TEL
0744-22-3051
Homepage URL
tom15@naramed-u.ac.jp
Sponsor or person
Institute
NARA medical university
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of NARA medical university
Address
840 Shijo-cho, Kashihara, Nara, Japan
Tel
0744-22-3051
ino_rinri@naramed-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
3187
Org. issuing International ID_1
ClinicalTrials.gov Protocol Registration and Results System
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
奈良県立医科大学他
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 20 | 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
4388
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Other
Management information
Registered date
| 2022 | Year | 02 | Month | 20 | Day |
Last modified on
| 2024 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053573
