UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014088
Receipt number R000016402
Scientific Title Effect of astaxanthin administration for heart failure patients with left ventricular systolic dysfunction.
Date of disclosure of the study information 2014/05/27
Last modified on 2020/09/12 13:41:51

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effect of astaxanthin administration for heart failure patients with left ventricular systolic dysfunction.

Acronym

Effect of astaxanthin administration for heart failure patients with left ventricular systolic dysfunction.

Scientific Title

Effect of astaxanthin administration for heart failure patients with left ventricular systolic dysfunction.

Scientific Title:Acronym

Effect of astaxanthin administration for heart failure patients with left ventricular systolic dysfunction.

Region

Japan


Condition

Condition

Heart failure due to left ventricular systolic dysfunction

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess whether three month administration of astaxanthin can induce 1) reductions of oxidative stress marker levels; 2) improvements of echocardiographic parameters for left ventricular functions; 3) reduction of plasma B-type natriuretic peptide level; 4) improvements of exercise tolerance; and 5) improvements of quality-of-life.
To assess whether there are correlation between changes in those parameters and increase in plasma level of astaxanthin.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) Changes in oxidative stress markers; 2) Changes in echocardiographic parameters; 3) Change in plasma B-type natriuretic peptide level; 4) Change in exercise tolerance; and 5) Changes in quality-of-life.

Key secondary outcomes

Correlations between primary outcomes and increase in plasma level of astaxanthin.


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

Treatment

Type of intervention

Food

Interventions/Control_1

Administration of astaxathin

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) left ventricular ejection fraction <50%
2) NYHA functional class >= II
3) Ability to answer questionnaires by themselves

Key exclusion criteria

1) Patients with organic valvular heart disease
2) Smokers
3) Patients under dialysis
4) Patients with chronic lung diseases
5) Patients with chronic inflammatory diseases
6) Patients with neoplasms
7) Patients who can not walk alone
8) Patients who were considered as ineligible by attending physicians

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Takatoshi
Middle name
Last name Kasai

Organization

Juntendo University

Division name

Department of Cardiology

Zip code

113-8421

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 Takatoshi
Middle name
Last name Kasai

Organization

Juntendo University

Division name

Department of Cardiology

Zip code

113-8421

Address

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

TEL

03-3813-3111

Homepage URL


Email

tkasai@juntendo.ac.jp


Sponsor or person

Institute

Department of Cardiology, Juntendo University

Institute

Department

Personal name



Funding Source

Organization

AstaReal Co., 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

aa

Address

aa

Tel

aa

Email

aa@juntendo.ac.jp


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

2014 Year 05 Month 27 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

Main results already published

Date of protocol fixation

2014 Year 05 Month 20 Day

Date of IRB

2014 Year 05 Month 23 Day

Anticipated trial start date

2014 Year 06 Month 01 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 05 Month 27 Day

Last modified on

2020 Year 09 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016402


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name