UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019905
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hasanoi@kmh.biglobe.ne.jp

Sponsor
Institute Clinical Research Support Center Kyushu
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022990

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.