UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031056
Receipt No. R000035464
Scientific Title Evaluation of kidney injury associated with atrial fibrillation (KIDI-AF)
Date of disclosure of the study information 2018/03/01
Last modified on 2019/01/31

* 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 Evaluation of kidney injury associated with atrial fibrillation (KIDI-AF)
Acronym Atrial fibrillation and renal function
Scientific Title Evaluation of kidney injury associated with atrial fibrillation (KIDI-AF)
Scientific Title:Acronym Atrial fibrillation and renal function
Region
Japan

Condition
Condition Persistent atrial fibrillation, Chronic kidney disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the mechanisms of renal impairment induced by atrial fibrillation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Serum Creatinine and eGFR and renal perfusion flow on 12 months after the catheter ablation procedure.
Key secondary outcomes Laboratory data, electrocardiography, ultrasonography, and other data on 12 months after the catheter ablation procedure.

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 Patients with chronic kidney disease (i.e. eGFR < 60ml/min/1.73cm2 and/or proteinuria) who underwent catheter ablation for persistent atrial fibrillation between February 1, 2018 to January 31, 2021 in Kanazawa Medical Center.
Key exclusion criteria Patients with hemodialysis. Patients who cannot make informed consent.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Sakagami
Organization National Hospital Organization, Kanazawa Medical Center
Division name Department of Cardiovascular medicine
Zip code
Address 1-1 shimo-ishibiki-machi, Kanazawa
TEL 076-262-4161
Email afib@kinbyou.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naomi Kanamori
Organization National Hospital Organization, Kanazawa Medical Center
Division name Department of Cardiovascular medicine
Zip code
Address 1-1 shimo-ishibiki-machi, Kanazawa
TEL 076-262-4161
Homepage URL
Email nhirota-circ@umin.ac.jp

Sponsor
Institute Department of Cardiovascular medicine, National Hospital Organization, Kanazawa Medical Center
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
Address
Tel
Email

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 独立行政法人国立病院機構金沢医療センター(石川県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 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
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
2017 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We investigate the parameters of cardiac and renal functions before and after catheter ablation of persistent atrial fibrillation.

Management information
Registered date
2018 Year 01 Month 30 Day
Last modified on
2019 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035464

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.