UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031942
Receipt number R000036458
Scientific Title A prospective clinical trial on effects of Suvorexant on Respiration and Hemodynamics during Sleep in Heart Failure patients.
Date of disclosure of the study information 2018/03/28
Last modified on 2022/10/03 13:54:17

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Basic information

Public title

A prospective clinical trial on effects of Suvorexant on Respiration and Hemodynamics during Sleep in Heart Failure patients.

Acronym

A prospective clinical trial on effects of Suvorexant on Respiration and Hemodynamics during Sleep in Heart Failure patients.

Scientific Title

A prospective clinical trial on effects of Suvorexant on Respiration and Hemodynamics during Sleep in Heart Failure patients.

Scientific Title:Acronym

A prospective clinical trial on effects of Suvorexant on Respiration and Hemodynamics during Sleep in Heart Failure patients.

Region

Japan


Condition

Condition

heart failure, insomnia

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of suvorexant on breathing and hemodynamics during sleep in heart failure patients with insomnia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Apnea Hypopnea Index

Key secondary outcomes

Cardiac Output, Stroke volume, Blood pressure, Total peripheral resistance, Heart rate


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administer Suvorexant (orexin receptor antagonist) for four days. Patients less than 65 years old will be administered a single 20 mg oral dose of suvorexant and patients over 65 years old will be administered a single 15 mg oral dose of suvorexant.

Interventions/Control_2

Not sleep medications as control.

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 admitted due to care of heart failure and diagnosed insomnia
and
2)Patients who gave written informed consent

Key exclusion criteria

1)Patients being dialysis
2)Patients can not take medicine orally
3)Patients using incompatible medicine which cause a major interaction with suvorexant.
4)Past organic cerebral disease
5)Severe liver dysfuncton
6)Patients applied inapropriate by responsible person
7)Patients have shock vital
8)Patietns using alpha blocker or nitrate medicine
9)Patients using oxygen therapy
10)Patients using CPAP therapy
11)Paitnets with pacemaker rhythm
12)Narcolepsy, Parasomnia or Sleep-related hypoventilation disorder

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takatoshi Kasai

Organization

Juntendo Hospital, Juntendo University School of Medicine

Division name

Cardiovascular Medicine

Zip code


Address

2-1-1 Hongo, Bunkyoku, Tokyo, Japan

TEL

03-3813-3111

Email

tkasai@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Jun Shitara

Organization

Juntendo Hospital, Juntendo University School of Medicine

Division name

Cardiovascular Medicine

Zip code


Address

2-1-1 Hongo, Bunkyoku, Tokyo, Japan

TEL

03-3813-3111

Homepage URL


Email

jshitara@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

we have no funding source

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 28 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

2017 Year 12 Month 20 Day

Date of IRB

2018 Year 01 Month 26 Day

Anticipated trial start date

2018 Year 01 Month 26 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 10 Month 31 Day

Date trial data considered complete

2022 Year 12 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 28 Day

Last modified on

2022 Year 10 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036458


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name