UMIN-CTR Clinical Trial

Basic information
Public title	Effect on ARNI on renal function and body fluid volume
Acronym	Effect on ARNI on renal function and body fluid volume
Scientific Title	Effect on ARNI on renal function and body fluid volume
Scientific Title:Acronym	Effect on ARNI on renal function and body fluid volume
Region	Japan

Condition
Condition	Congestive heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect on ARNI on renal function and body fluid volume
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Urine volume from day 0 to day 5.
Key secondary outcomes	Transition of creatinine, eGFR, body weight, NAG and NT-proBNP from day 0 to day 5. The incidence of death and rehospitalization for heart failure within 60 days.

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 20 years of age or older were eligible for inclusion in trial if they had left ventricular ejection fraction of 40% or less and had primary diagnosis of congestive heart failure (2)Stable cardiohemodynamics(sBP >= 90 mmHg) (3)Not in use inotrope
Key exclusion criteria	(1)contraindication in packge insert (2)Cardiogenic shock (3)ACS (4)Pregnancy (5)A patient who started clinical trials (6)A patient who couldn't attend a hospital (7)A patient improper to this clinical trial according to the decision of a principal investigator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yu Middle name Last name Horiuchi
Organization	Mitsui Memorial Hospital
Division name	Division of Cardiology
Zip code	101-8643
Address	Kanda-Izumicho 1, Chiyoda-ku, Tokyo
TEL	03-3862-9111
Email	yooouyou@gmail.com

Public contact
Name of contact person	1st name Naoto Middle name Last name Setoguchi
Organization	Mitsui Memorial Hospital
Division name	Division of Cardiology
Zip code	101-8643
Address	Kanda-Izumicho 1, Chiyoda-ku, Tokyo
TEL	03-3862-9111
Homepage URL
Email	naoto.stgc@gmail.com

Sponsor
Institute	Mitsui Memorial hospital
Institute
Department

Funding Source
Organization	Mitsui 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	Mitsui Memorial Hospital
Address	Kanda-Izumicho 1, Chiyoda-ku, Tokyo
Tel	03-3862-9111
Email	c-uno@mitsuihosp.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	2020 Year 12 Month 05 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	Main results already published
Date of protocol fixation	2020 Year 10 Month 29 Day
Date of IRB	2020 Year 11 Month 27 Day
Anticipated trial start date	2021 Year 01 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 08 Month 01 Day

Other
Other related information	prospective observational study

Management information
Registered date	2020 Year 12 Month 04 Day
Last modified on	2022 Year 08 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048662