UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019905 |
|---|---|
| Receipt number | R000022990 |
| Scientific Title | Multicenter, prospective study on respiratory stability through recovery process from deterioration of heart failure in patients with chronic heart failure. |
| Date of disclosure of the study information | 2015/11/24 |
| Last modified on | 2016/07/26 13:22:37 |
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Basic information
Public title
Multicenter, prospective study on respiratory stability through recovery process from deterioration of heart failure in patients with chronic heart failure.
Acronym
Prospective study on respiratory stability through recovery process from deterioration of heart failure (PROST)
Scientific Title
Multicenter, prospective study on respiratory stability through recovery process from deterioration of heart failure in patients with chronic heart failure.
Scientific Title:Acronym
Prospective study on respiratory stability through recovery process from deterioration of heart failure (PROST)
Region
| Japan |
Condition
Condition
Chronic Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is carried out to examine whether respiratory stability changes through a recovery process during hospitalization due to heart failure deterioration in patients with chronic heart failure. Respiratory stability is assessed by respiratory stability index (RSI) which is calculated from respiratory wave for an overnight and a daytime brief measurement.
Basic objectives2
Others
Basic objectives -Others
Usefulness of Respiratory Stability Index (RSI)
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Change of a mean RSI calculated for the overnight respiratory measurement.
2) Change of RSI calculated for the daytime brief respiratory measurement.
Key secondary outcomes
Change of a median RSI calculated for the overnight respiratory measurement.
Change of the mean and a standard deviation of a respiratory cycle, a mean ventilatory frequency, apnea hypopnea index (AHI), 3% oxygen desaturation index (ODI), a mean percutaneous oxygen saturation (SpO2) calculated for the overnight respiratory measurement.
Change of the mean and the standard deviation of respiratory cycle, the ventilatory frequency, a mean tidal volume, an end-tidal carbon dioxide concentration (ETCO2) and an end-tidal oxygen concentration (ETO2) calculated for the daytime brief respiratory measurement.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
1) Overnight respiratory measurement (sleep study)
The overnight respiratory measurement is carried out using a portable polygraph (type 3), SAS-3200 during the bedtime. The air flow is measured using a cannule (pressure sensor). A pulse oximetry is concomitantly carried out for assessment of sleep apnea.
2) Daytime brief respiratory measurement
The daytime brief respiratory measurement is carried out using a pulmonary exercise tolerance monitoring system [AE-300S AE-310S or Cpex-1]. The analog signals such as the air flow, the expiratory oxygen concentration, the expiratory carbon dioxide concentration are converted to digital signals and consecutively collected to a personal computer (PC) for 6 minutes.
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) Patients with chronic heart failure are hospitalizing due to heart failure deterioration.
2) Patients in whom the investigator considered that respiratory intervention (such as positive ventilation or oxygen inhalation etc.) is unnecessary or will be unnecessary.
3) Patient with 20 years or older.
4) Patients or proxy providing the written informed consent.
Key exclusion criteria
1) Patient considered to be not able to measure overnight respiratory (such as rhinostenosis).
2) Patients within three months from the onset of acute coronary syndrome (ACS).
3) Patients without an independent walking before the hospitalization.
4) Patients having a chronic respiratory failure or chronic obstructive pulmonary disease.
5) Patients with a central nervous disorder by stroke or injury.
6) Patients with hemodialysis.
7) Patients whose QOL is limited by malignant tumor or other diseases.
8) Patients who are inability or doubted for an agreement before deterioration of heart failure.
9) Any other patients who are regarded as unsuitable for this study by the investigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetsugu Asanoi |
Organization
Imizu Municipal Hospital
Division name
Department of Internal Medicine/Cardiology
Zip code
Address
Hounoki 20, Imizu-city, Toyama 934-0053, Japan
TEL
0766-82-8100
hasanoi@kmh.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidetsugu Asanoi |
Organization
Imizu Municipal Hospital
Division name
Department of Internal Medicine/Cardiology
Zip code
Address
Hounoki 20, Imizu-city, Toyama 934-0053, Japan
TEL
0766-82-8100
Homepage URL
hasanoi@kmh.biglobe.ne.jp
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
Funding Source
Organization
Teijin Pharma Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
射水市民病院（富山県）、自治医科大学附属さいたま医療センター（埼玉県）、富山大学附属病院（富山県）、JCHO高岡ふしき病院（富山県）、三重大学医学部附属病院（三重県）、九州大学病院（福岡県）、済生会二日市病院（福岡県）、秋田大学医学部附属病院（秋田県）、産業医科大学若松病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 24 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 24 | Day |
Last modified on
| 2016 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022990
