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

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 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


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

Value
https://center6.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