UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037560 |
|---|---|
| Receipt number | R000042328 |
| Scientific Title | Verification of usefulness of cardiac telerehabilitation for elderly patients with heart failure |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2023/08/28 14:21:33 |
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Basic information
Public title
Verification of usefulness of cardiac telerehabilitation for elderly patients with heart failure
Acronym
e-FIT HF trial
Scientific Title
Verification of usefulness of cardiac telerehabilitation for elderly patients with heart failure
Scientific Title:Acronym
e-FIT HF trial
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect on exercise capacity of combination therapy of conventional outpatient cardiac rehabilitation (CR) and cardiac telerehabilitation for elderly patients with heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of patients who improved peak VO2 by more than 6% after three months of CR
Key secondary outcomes
The rate of change of the following indicators during three months of CR
1. Peak VO2
2. Peak work rate
3. 6-minute walking distance
4. Brain natriuretic peptide
5. Body weight
6. Body composition
7. Nutritional index
8. Depression index
9. Serum lipid level
10. Blood sugar level, HbA1c
11. Renal function
12. Blood pressure
13. Heart failure self-care ability
The following indicators during three months of CR
14. Physical activity
15. Rate of smoking cessation
16. Participation rate in CR
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Combination therapy of conventional outpatient CR and cardiac telerehabilitation
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who are indicated for outpatient CR
2. Patients with heart failure
3. Patients with written consent
4. Over 60 years old
Key exclusion criteria
1. NYHA class 4
2. Patients with LVEF of 40% or less who developed myocardial infarction within 90 days
3. History of syncope or cardiopulmonary arrest(CPA) with unknown cause or no treatment
4. History of syncope, CPA or ICD/CRT-D appropriate or inappropriate therapy within the past one year(Patients with implantable devices are excluded after April 24, 2020)
5. Unstable angina or lower threshold angina
6. Severe stenotic valvular disease
7. The Following adverse events occur when the exercise intensity is less than the anaerobic threshold at the time of symptom-limited exercise test or CR before cardiac telerehabilitation introduction
7.1 Nonsustained/sustained ventricular tachycardia or ventricular fibrillation
7.2 R on T type ventricular premature contraction (VPC)
7.3 Frequent VPC (more than 30%)
7.4 Couplet VPC (two or more times a minute)
7.5 Second- or third-degree atrioventricular block
7.6 progressive blood pressure drop during exercise
7.7 Vagal reflexes after exercise below the exercise prescription intensity (Vagal reflexes after symptom-limited exercise test are not included in the exclusion criteria)
8. Schedule within three months for cardiovascular surgery, and implantation of pacemakers (including CRT) and ICDs
9. Patients with ventricular assist devices
10. End-stage patients
11. Patients who have difficulty operating the cardiac telerehabilitation system
12. Patients who can not establish a telecommunication system at home
13. Patients who have difficulty in securing time for participation in CR due to working or schooling
14. Patients who have already participated in or plan to participate in other clinical trials (except for registry studies)
15. Patients for whom the study investigator or the attending physician judged inappropriate to participate in this study
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miura |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular medicine
Zip code
564-8565
Address
6-1 Kishibe Shinmachi, Suita, Osaka, Japan
TEL
06-6170-1070
h_miura8217@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miura |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular medicine
Zip code
564-8565
Address
6-1 Kishibe Shinmachi, Suita, Osaka, Japan
TEL
06-6170-1070
Homepage URL
h_miura8217@yahoo.co.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science and technology (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
Remohab Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
6-1 Kishibe Shinmachi, Suita, Osaka, Japan
Tel
06-6170-1070
h_miura8217@yahoo.co.jp
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
国立循環器病研究センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
5
Results
No analysis due to study discontinuation
(Study discontinued due to failure to reach sufficient number of patients)
Results date posted
| 2023 | Year | 08 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No analysis due to study discontinuation
Participant flow
No analysis due to study discontinuation
Adverse events
No analysis due to study discontinuation
Outcome measures
No analysis due to study discontinuation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2019 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | 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 | 07 | Month | 31 | Day |
Last modified on
| 2023 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042328
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