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Recruitment status Terminated
Unique ID issued by UMIN UMIN000010076
Receipt No. R000011803
Scientific Title The effect of adaptive servo ventilation therapy on cardiovascular disease in heart failure patients with cardiac implantable electronic devices.
Date of disclosure of the study information 2013/02/20
Last modified on 2015/02/27

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Basic information
Public title The effect of adaptive servo ventilation therapy on cardiovascular disease in heart failure patients with cardiac implantable electronic devices.
Acronym The effect of adaptive servo ventilation therapy on cardiovascular disease
Scientific Title The effect of adaptive servo ventilation therapy on cardiovascular disease in heart failure patients with cardiac implantable electronic devices.
Scientific Title:Acronym The effect of adaptive servo ventilation therapy on cardiovascular disease
Region
Japan

Condition
Condition chronic heart failuree
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of adaptive servo ventilation therapy on following cardiovascular disease parameters (arrhythymia, cardiac function, endothelial function, immflammatory markers, oxidative stress and sympathetic nervus system, etc) in reduced ejection fraction (EF<=45%) heart failure patients with carac implantable veces (ICD, Pacemaker, CRT-D).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Absolute and percent changes in frequencies of arrythmia(atrial or ventricular arrhythmia) that are stored in the cardiac implantable electronic devices.
Key secondary outcomes To assess the concomitant effects of the adaptive servo ventilation therapy and their mechanisms, we also evaluate the absolute and percent changes in following parameters;
*cardiac function assessed by echocardiography,
*endothelial function (Endo-PAT2000),
*oxidative stress markers (dROM/BAP etc),
*sleep disorder breathing (AHI),
*exercise capacity (5m gait speed),
*metabolic status (lipid/glycemic parameters),
*renal function,
*symptom/QOL,
*impedance assessed by devices,
*body weight,
*drug component,
*Prognosis (death, heart failure, etc)


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 YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Group1;
Adaptive servo ventilation therapy from Day 1 to Day 90. After that, we crossover the patients and stop the adaptive servo ventilation therapy from Day 91 to Day 180.
Interventions/Control_2 Group2;
No adaptive servo ventilation therapy from Day 1 to Day 90. After that, we crossover the patients and start the adaptive servo ventilation therapy.
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) At the age of 20 or above (at consent acquisition)
(2) Patients with cardiac implantable electronic devices (Pace maker, ICD and CRT-D).
(3)Heart failure patients whose EF is 45% or less than 45%.
(4) Patients with standard optimal drug therapy (beta blocker, ACEI/ARB, etc) who did not any episode of admission due to decompensated heart failure within 3 months.
(5) Patients who give written consent to participation in the study at their own will.
Key exclusion criteria (1) Patients with cancer, severe infection and traumatic disease.
(2) Other patients deemed unsuitable by the principal investigator or investigator.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Kimura
Organization Yokohama City University Medical Center
Division name Devision of Cardiology
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email kozookada@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kozo Okada
Organization Yokohama City University Medical Center
Division name Division of Cardiology
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email kozookada@gmail.com

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
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 横浜市立大学附属市民総合医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 20 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 Terminated
Date of protocol fixation
2013 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 06 Day
Last follow-up date
2018 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 19 Day
Last modified on
2015 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011803

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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