UMIN-CTR Clinical Trial

Basic information
Public title	Long-term effects of antihypertensive drugs on renal prognosis in patients with hypertensive emergency
Acronym	Long-term effects of antihypertensive drugs on renal prognosis in patients with hypertensive emergency
Scientific Title	Long-term effects of antihypertensive drugs on renal prognosis in patients with hypertensive emergency
Scientific Title:Acronym	Long-term effects of antihypertensive drugs on renal prognosis in patients with hypertensive emergency
Region	Japan

Condition
Condition	Hypertensive emergency
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify renal protective effect of RAS inhibitores in hypertensive emergency patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The changes in eGFR over 2 years in hypertensive emergency patients
Key secondary outcomes	The ratio of non-dialysis dependence over 2 years in hypertensive emergency patients

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients whose systolic or diastolic blood pressure more than 180 or 120 mmHg, respectivel visited the emergency department of Tokyo Bay Urayasu-Ichikawa Medical Center and diagnosed as having heart failure, acute kidney injury, thrombotic microangiopathy, severe hypertensive retinopathy or hypertensive encephalopathy
Key exclusion criteria	patients who transferred to other hospitals without admission, 5 patients who required maintenance dialysis therapy upon hospitalization and 14 patients whose renin and aldosterone were not measured during hospitalization
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Toshihiko Middle name Last name Suzuki
Organization	Tokyo Bay Urayasu Ichikawa Medical Center
Division name	Department of Nephrology, Endocrinology and Diabetes
Zip code	2790001
Address	3-4-32 Todaijima, Urayasu, Chiba, Japan
TEL	0473513101
Email	toshi-s@xj9.so-net.ne.jp

Public contact
Name of contact person	1st name Keita Middle name Last name Endo
Organization	Tokyo Bay Urayasu Ichikawa Medical Center
Division name	Department of Nephrology, Endocrinology and Diabetes
Zip code	2790001
Address	3-4-32 Todaijima, Urayasu, Chiba, Japan
TEL	0473513101
Homepage URL
Email	keitaendo78@gmail.com

Sponsor
Institute	Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department

Funding Source
Organization	Tokyo Bay Urayasu Ichikawa Medical Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Bay Urayasu Ichikawa Medical Center
Address	3-4-32 Todaijima, Urayasu, Chiba, Japan
Tel	0473513101
Email	toshi-s@xj9.so-net.ne.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 04 Month 01 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	49
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	2021 Year 09 Month 01 Day
Date of IRB	2021 Year 11 Month 26 Day
Anticipated trial start date	2021 Year 09 Month 02 Day
Last follow-up date	2022 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	patient characteristics Age Sex systolic and diastolic blood pressure heart rate Cre eGFR Proteinuria(P/C) medications (RAS inhibitor, Ca channel blocker, beta blocker, diuretics) Echocardiogram plasma renin activity plasma aldosterone concentration renal ultrasound blood pressure, Cre, P/C after discharge

Management information
Registered date	2022 Year 03 Month 31 Day
Last modified on	2022 Year 03 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052943