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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037560
Receipt No. 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 2020/01/29

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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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients scheduled to participate in outpatient CR
2. Patients admitted to our hospital for heart failure and started CR during hospitalization or within two weeks after hospital discharge
3. Patients with written consent
4. Over 65 years old
Key exclusion criteria 1. NYHA class 4
2. Myocardial infarction within one month
3. History of syncope or cardiopulmonary arrest with unknown cause or no treatment
4. History of syncope, cardiopulmonary arrest or ICD/CRT-D appropriate or inappropriate therapy within the past one year
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. Receiving intravenous catecholamine
11. Pregnant women, lactating women or women who can not agree to contraception during the study
12. End-stage patients
13. Patients who received CR (group session) for more than one month before discharge
14. Patients who have difficulty operating the cardiac telerehabilitation system
15. Patients who can not establish a telecommunication system at home
16. Patients who have difficulty in securing time for participation in CR due to working or schooling
17. Patients who have already participated in or plan to participate in other clinical trials (except for registry studies)
18. 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
Email 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
Email h_miura8217@yahoo.co.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
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
2020 Year 08 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
2020 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042328

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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