UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of traditional Japanese Kampo effects in patients with chronic heart failure
Title of the study (Brief title)	Japanese Kampo medicine in chronic heart failure
Region	Japan

Condition
Condition	Chronic heart failure
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assessment of efficacy and safety of Japanese Kampo medicine in patients with chronic heart failure
Basic objectives2	Others
Basic objectives -Others	This study was designed to evaluate status of heart failure and renal function after treatment with Kampo medicine in chronic heart failure patients with cardiorenal syndrome.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Status of heart failure (NYHA classification, level of brain natriuretic peptide) Renal function (levels of serum creatinine, estimated glomerular filtration ratio)
Key secondary outcomes	Adverse effects

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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Chronic heart failure patients with cardiorenal syndrome: 1) Stable compensated patients with chronic heart failure classified as New York Heart Association (NYHA) functional class I-III. 2) Chronic heart failure Stage B or Stage C 3) Estimated glomerular filtration rate, eGFR < 65 mL/min/1.73 m2
Key exclusion criteria	Patients with: 1) intravascular volume depletion 2) indications for hemodialysis or acute kidney injury 3) sepsis or ongoing infection 4) alcohol and/or drug abuse 5) hepatic insufficiency 6) known allergy to the study medication or any of its components 7) enrollment in other clinical trials involving medical or device based interventions
Target sample size	30

Research contact person
Name of lead principal investigator	Uichi Ikeda
Organization	Shinshu University School of Medicine
Division name	Department of Cardiovascular Medicine
Address	3-1-1 Asahi, Matsumoto 390-8621, Nagano, Japan
TEL	0263-37-3352
Email	uikeda@shinshu-u.ac.jp

Public contact
Name of contact person	Atsushi Izawa
Organization	Shinshu University School of Medicine
Division name	Department of Cardiovascular Medicine
Address	3-1-1 Asahi, Matsumoto 390-8621, Nagano, Japan
TEL	0263-37-3352
Homepage URL
Email	izawa611@shinshu-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Shinshu University School of Medicine
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	2014 Year 01 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 01 Day
Anticipated trial start date	2012 Year 04 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Clinical endpoints were analysed at 3 points as follows: 1) before initiation of the treatment, and followed at mean intervals of 2) 3.5 and 3) 9.4 months after starting the treatment.

Management information
Registered date	2014 Year 01 Month 06 Day
Last modified on	2016 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014684