UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037066 |
|---|---|
| Receipt number | 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 09:52:51 |
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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
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
taniyan6dec@yahoo.co.jp
Sponsor or person
Institute
Nagoya Ekisaikai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042233
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