UMIN-CTR Clinical Trial

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
Email	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
Email	hiromail1979@s.okayama-u.ac.jp

Sponsor
Institute	Okayama university
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053468