UMIN-CTR Clinical Trial

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

chronic heart failuree

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Yokohama City University Medical Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

横浜市立大学附属市民総合医療センター（神奈川県）

Date of disclosure of the study information

2013

Year

02

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

02

Month

19

Day

Last modified on

2015

Year

02

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011803