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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037066
Receipt No. R000042233
Scientific Title Feasibility of neuromuscular electrical stimulation in patients with acute heart failure
Date of disclosure of the study information 2019/06/14
Last modified on 2019/06/14

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Basic information
Public title Feasibility of neuromuscular electrical stimulation in patients with acute heart failure
Acronym Feasibility of NMES in AHF
Scientific Title Feasibility of neuromuscular electrical stimulation in patients with acute heart failure
Scientific Title:Acronym Feasibility of NMES in AHF
Region
Japan

Condition
Condition Acute heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Feasibility of neuromuscular electrical stimulation (NMES) in patients with acute heart failure
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fulfill the preset feasibility criteria
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Neuromuscular electrical stimulation of 10-20% maximal voluntary contraction on lower leg, since the day after admission until discharge, five days a week, 30-60 minutes
Interventions/Control_2 Neuromuscular electrical stimulation of 10-20Neuromuscular electrical stimulation of a visible or palpable level of muscle contraction on lower leg, since the day after admission until discharge, five days a week, 30-60 minutes maximal voluntary contraction on lower leg, since the day after admission until discharge, five days a week, 30-60 minutes
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 who were admitted due to acute heart failure and had ambulatory ability before admission.
Key exclusion criteria (1) New York Heart Association functional class I or II
(2) acute coronary syndrome
(3) intra-aortic balloon pump or extracorporeal membrane oxygenation
(4) systolic blood pressure (BP) < 80 mmHg even with inotropic or vasopressor support
(5) intubation
(6) agitation requiring sedation physically or by medication
(7) severe ventricular arrhythmia.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Yamada
Middle name
Last name Sumio
Organization Nagoya University Graduate School of Medicine
Division name Department of Health Sciences
Zip code 461-8673
Address 1-1-20 Daiko Minami Higashi-ku, Nagoya
TEL 052-719-1346
Email yamadas@met.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Tanimura
Middle name
Last name Daisuke
Organization Nagoya Ekisaikai hospital
Division name Department of Cardiology
Zip code 454-8502
Address 4-66 Matsunencho Nakagawa-ku, Nagoya
TEL 052-652-7711
Homepage URL
Email taniyan6dec@yahoo.co.jp

Sponsor
Institute Nagoya Ekisaikai Hospital
Institute
Department

Funding Source
Organization None
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 None
Address None
Tel None
Email None

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
2019 Year 06 Month 14 Day

Related information
URL releasing protocol None
Publication of results Partially published

Result
URL related to results and publications None
Number of participants that the trial has enrolled 78
Results
Changes in BP > +/-20 mmHg or HR > +20 bpm were observed in 3 cases in NMES group (8.8%) and 5 in control group(12.8%). New-onset arrhythmia was not observed during all session. During hospitalization, 1 patient in each group newly developed AF and lethal ventricular arrhythmias were documented in 3 patients in control group. 31 patients in NMSE group (91%) and 33 patients in control group (84%) completed the planned sessions during hospitalization. This study fulfilled the preset feasibility criteria.
Results date posted
2019 Year 06 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
median age 72 years, 51 men, mean left ventricular ejection fraction 40.4%
Participant flow
Among 372 subjects who were admitted for acute heart failure, 78 were allocated. A total of 73 patients who finished the first session were analyzed (NMES group: n=34, control group: n=39). 
Adverse events
Cerebral infarction developed in two patients in the NMES group and one in the control group. Lethal ventricular arrhythmia was documented in two patients in the control group. Two patients showed worsening of HF requiring endotracheal intubation more than 24 h after admission and one patient in the control group died during hospitalization. Heart failure symptom including dyspnea and fatigue did not change just before and after and during sessions in all cases. No patients showed electromagnetic interference during the first session. 
Outcome measures
(1) change in systolic blood pressure (BP) > +/-20 mmHg during the first session; (2) increase in heart rate (HR) > + 20 bpm during the first session; (3) development of sustained ventricular arrhythmia, atrial fibrillation (AF), and paroxysmal supraventricular tachycardia during all sessions; (4) incidence of new-onset AF during the hospitalization period < 40%; and (5) completion of the planned sessions by > 70% of patients. The criteria of feasibility were set as follows; the percentage to fill one of (1)-(3) was < 20% of the total subjects and both (4) and (5) were satisfied.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 05 Month 17 Day
Date of IRB
2013 Year 07 Month 22 Day
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2015 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 14 Day
Last modified on
2019 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042233

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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