UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of predictive value of heart rate variability indicators for transplant-related mortality in hematopoietic stem cell transplantation
Title of the study (Brief title)	The study of predictive value of heart rate variability indicators for transplant-related mortality in hematopoietic stem cell transplantation
Region	Japan

Condition
Condition	Patients scheduled to undergo allogeneic hematopoietic stem cell transplantation
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze an impact of heart rate variability indicators on prognosis including transplant-related mortality after allogeneic hematopoietic stem cell transplantation
Basic objectives2	Others
Basic objectives -Others	Prognostic prediction
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The impact of heart rate variability indicators on transplant related mortality after allogeneic hematopoietic stem cell transplantation
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are eligible for allogeneic hematopoietic stem cell transplantation and scheduled to undergo allogeneic hematopoietic stem cell transplantation in our hospital
Key exclusion criteria	(1) Difficulty in sticking tape attachments of cardiac sensor for 24-hour ECG monitoring to the skin due to cutaneous lesion or any other condition (2) The rate of supraventricular or ventricular premature contractions exceed 5 or more percent of total heart beats (3)Patients with chronic atrial fibrillation (4)No indication for this study judged by physician in charge
Target sample size	115

Research contact person
Name of lead principal investigator	Masayuki Hino
Organization	Osaka City University, Graduate School of Medicine
Division name	Hematology
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL	06-6645-3881
Email	hinom@med.osaka-cu.ac.jp

Public contact
Name of contact person	Mika Nakamae
Organization	Osaka City University, Graduate School of Medicine
Division name	Hematology(Clinical research center for hematological malignancies )
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL	06-6645-3881
Homepage URL
Email	crc-hematology@med.osaka-cu.ac.jp

Sponsor
Institute	Hematology, Osaka City University, Graduate School of Meicine
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)

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	2010 Year 04 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 04 Month 06 Day
Anticipated trial start date	2010 Year 05 Month 27 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	We analyze heart rate variability before conditioning for transplantation and on day 30 after transplantation, and assess an impact on prognosis including transplant-related mortality after allogeneic hematopoietic stem cell transplantation. Prospective study. Procedure Patients undergo the 24-hour ambulatory ECG recording once before conditioning for allogeneic hematopoietic stem cell transplantation and on day 30 after transplantation. The stored ECG data is analyzed by a software for heart rate variability analysis (MemCalc/CHIRAM version 1, Suwatrust, Tokyo, Japan).

Management information
Registered date	2010 Year 04 Month 15 Day
Last modified on	2018 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004011