UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A single center, open-labeled, pilot study to evaluate the safety and efficacy of cardiac cycle-synchronized electrical lower limb muscle stimulation therapy for cardiovascular disease
Title of the study (Brief title)	Cardiac cycle-synchronized electrical lower limb muscle stimulation therapy for cardiovascular disease
Region	Japan

Condition
Condition	Latent heart failure (NYHA class: II-III), ischemic heart disease (CCS class: II-III), peripheral artery disease (Fontaine class: II-IV), pulmonary artery hypertension (WHO class: II-III), and healthy adult
Classification by specialty	Cardiology Geriatrics Vascular surgery Orthopedics Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of cardiac cycle-synchronized electrical lower limb muscle stimulation therapy for cardiovascular disease patients with a decrease in the activity of daily living
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	At the end of the therapy, we will assess following safeties and efficacies. Safety: skin and/or muscle injury by electrical stimulation, cardiovascular adverse events, and hemodynamic change. Efficacy: daily symptoms, physical examination, glycolipid metabolism, cardiovascular function, hemodynamics, locomotive function, and body compositions including fat, muscle, and bone.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The subject is set up the cardiac cycle-synchronized electrical lower limb muscle stimulation system in the decubitus position. Then the subject trains the lower limb muscle for 20 minutes by controlled electrical muscle stimulation without an increase in the cardiac workload. The muscle training is performed twice a day, two or three times a week, and for up to 24 weeks.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Latent CHF NYHA class: II-III CTR<70% on chest X-P LVEF>30% on echo-cardiogram Ischemic heart disease Old myocardial infarction or stable angina with treated by acceptable revascularization before 30 days Peripheral artery disease Arteriosclerosis obliterans or Buergers disease with treated by acceptable revascularization before 30 days Fontaine class: II-IV Pulmonary artery hypertension WHO class: II-III Mean pulmonary artery pressure<50 mmHg No deep vein thrombus and pulmonary artery thrombus * It is necessary that any subjects have already received possible treatment before the entry.
Key exclusion criteria	Hard fitting of the equipment of this study Skin, muscle, or bone disease in limbs Implantation of cardiac pacemaker Uncontrolled hypertension Blood pressure at rest>160/100 mmHg Uncontrolled arrhythmia Arrhythmia with unstable hemodynamics Pregnancy Malignant disease on no-remission
Target sample size	30

Research contact person
Name of lead principal investigator	Ken-ichiro Sasaki
Organization	Kurume University School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
Address	Asahi-machi 67, Kurume, 830-0011
TEL	0942-31-7562
Email	sasaken@med.kurume-u.ac.jp

Public contact
Name of contact person	Ken-ichiro Sasaki
Organization	Kurume University School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
Address	Asahi-machi 67, Kurume, 830-0011
TEL	0942-31-7562
Homepage URL
Email	sasaken@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University School of Medicine, Division of Cardiovascular Medicine, Department of Internal Medicine
Institute
Department

Funding Source
Organization	Kurume University School of Medicine, Division of Cardiovascular Medicine, Department of Internal Medicine
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	2017 Year 04 Month 04 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 10 Month 26 Day
Anticipated trial start date	2015 Year 11 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 03 Day
Last modified on	2018 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030807