UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046870 |
|---|---|
| Receipt number | R000053468 |
| Scientific Title | Vericiguat Registry Multicenter prospective observational study |
| Date of disclosure of the study information | 2022/02/08 |
| Last modified on | 2022/02/08 22:07:54 |
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Basic information
Public title
Vericiguat Registry
Acronym
Vericiguat Registry
Scientific Title
Vericiguat Registry Multicenter prospective observational study
Scientific Title:Acronym
Vericiguat Registry
Region
| Japan |
Condition
Condition
Chronic heart failure with reduced ejection fraction(HFrEF)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in heart failure symptoms and hemodynamic indices before and after treatment in patients receiving vericiguat for heart failure with reduced ejection fraction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Right heart function indices by echocardiography at 24 weeks (RVFAC, RV diameter (base, mid, longitudinal), RV thickness, RV s', TAPSE)
Key secondary outcomes
NTproBNP (12 weeks, 24 weeks)
High-sensitivity troponin T (12 weeks, 24 weeks)
KCCQ (12 weeks, 24 weeks)
NYHA (12 weeks, 24 weeks)
Echocardiographic indices
Vericiguat dose (12 weeks, 24 weeks, 1 year)
Clinical outcomes (death, cardiovascular death, hospitalization for worsening heart failure)
Incidence of adverse events
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients who will be seen between the Ethics Committee approval and March 31, 2024.
(2) Patients who are able to provide written consent to participate in the study of their own free will.
(3) Patients whose age at the time of consent is 20 years or older.
4) Gender: male or female
5) Left ventricular ejection fraction (LVEF) <45% observed within 12 months
6) NYHA>=II degree
7) Patients undergoing standard treatment for chronic heart failure
(viii) Patients scheduled to receive Vericiguat
Key exclusion criteria
(1) Women who are pregnant or may become pregnant
(2) Patients with a history of hypersensitivity to Vericiguat
(3) Patients receiving soluble guanylate cyclase (sGC) stimulator (riociguat)
3) Patients receiving soluble guanylate cyclase (sGC) stimulant (riociguat). 4) Other patients who are deemed unsuitable for this study by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ito |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kitaku, Okayama
TEL
0081862357351
itomd@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hironobu |
| Middle name | |
| Last name | Toda |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kitaku, Okayama
TEL
0081862357351
Homepage URL
hiromail1979@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama university
Institute
Department
Personal name
Funding Source
Organization
none
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
Ethical Committee of Okayama University
Address
2-5-1 Shikata-cho, Kitaku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-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
| 2022 | Year | 02 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter, prospective observational study (cohort study)
Management information
Registered date
| 2022 | Year | 02 | Month | 08 | Day |
Last modified on
| 2022 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053468
