UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049976 |
|---|---|
| Receipt number | R000056644 |
| Scientific Title | Investigation of safety and efficacy of cardiac rehabilitation for pulmonary hypertension |
| Date of disclosure of the study information | 2023/01/10 |
| Last modified on | 2023/01/06 14:56:06 |
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Basic information
Public title
Investigation of safety and efficacy of cardiac rehabilitation for pulmonary hypertension
Acronym
Investigation of safety and efficacy of cardiac rehabilitation for pulmonary hypertension
Scientific Title
Investigation of safety and efficacy of cardiac rehabilitation for pulmonary hypertension
Scientific Title:Acronym
Investigation of safety and efficacy of cardiac rehabilitation for pulmonary hypertension
Region
| Japan |
Condition
Condition
Investigation of safety and efficacy of cardiac rehabilitation for pulmonary hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pulmonary hypertension (PH) is characterized by narrowing and occlusion of pulmonary artery which cause elevation of pulmonary vascular resistance. There are many young-onset patients and continuous administration of cardiotonic agents or lung transplantation are often needed in severe cases. Nowadays progress in treatments of PH including drug and catheter intervention have improved the outcome of PH; however, there are many patients in whom oxygeneration of blood remains low in spite of improved hemodynamics. In those patients, quality of life are reduced and solution for improvement of oxygeneration is needed.It is well known that cardiac rehabilitation, one of the non-pharmacological treatment, ameriolates mortality and incidence of adverse cardiac event with patients with left ventricular heart failure. Some of clinical trials demonstrated the efficacy of cardiac rehabilitation in pulmonary hypertension (Circulation. 2006;114:1482, European Heart Journal. 2016;37:35); however, number of patients was small in those studies and further studies are needed to prove the efficacy of cardiac rehabilitation in pulmonary hypertension.
The adoption rate of cardic rehabilitation is still low and pandemic of coronavirus infection made it difficult for patients to recieve outpatient rehabilitation. Thus, establishment of home-based cardiac rehabilitation would improve the adoption rate of cardiac rehabilitation.(Circulation: Cardiovascular Quality and Outcomes. 2020;13:e005902). In this clinical trial, we aim to prove the safety and efficacy of home-based cardiac rehabilitation for pulmonary hypertension .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of morality, the ratio of the patients with adverse cardiovascular events, the ratio of the patients who needed intensive treatment, and the ratio of the patients with addmision during non-intervention period (3months) and rehabilitation period (3month).
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Cardiac rehabilitation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Males and females who is 20 years old or over.
2. Patients who are treated for pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension in the Univeresity of Tokyo Hospital and whose mean pulmonary arterial pressures are under 25 mmHg within 6 month before starting this clinical trial.
3. Patients with informed consent for clinical trial enrollment.
Key exclusion criteria
1. Patients who are not appropriate for excercise
2. Patients in whom excercise is thought to be contraindication or who are at high risk for complication of excercise (Patients with severe valvular diseases, severe arrythmia, severe renal dysfunction, severe hepatic dysfunction, and carcinoma)
3. Patients with dimentia
4. Patientsin the terminal phase of the disease
5. Patients with pregnancy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Minatsuki |
Organization
The University of Tokyo Hospital
Division name
Department of cardiovacular medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0338155411
shunminatsuki@gmail.com
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Fujiwara |
Organization
The University of Tokyo Hospital
Division name
Department of Computational Diagnostic Radiology and Preventive Medicine
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0338155411
Homepage URL
sasasatf5804@yahoo.co.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuda Foundation for Medical Technology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committe, the faculty of medicine, the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
0338155411
ethics@m.u-tokyo.ac.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2023 | Year | 01 | Month | 06 | Day |
Last modified on
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056644
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