UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter, prospective study on respiratory stability through recovery process from deterioration of heart failure in patients with chronic heart failure.
Title of the study (Brief title)	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hidetsugu Asanoi
Organization	Imizu Municipal Hospital
Division name	Department of Internal Medicine/Cardiology
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	Hidetsugu Asanoi
Organization	Imizu Municipal Hospital
Division name	Department of Internal Medicine/Cardiology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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