UMIN-CTR Clinical Trial

Public title

The Clinical Significance of Plasma Pentraxin 3 levels for Patients with Diastolic Heart Failure

Acronym

Pentaraxin 3 in Left Ventricular Diastolic Dysfunction

Scientific Title

The Clinical Significance of Plasma Pentraxin 3 levels for Patients with Diastolic Heart Failure

Scientific Title:Acronym

Pentaraxin 3 in Left Ventricular Diastolic Dysfunction

Region

Japan

Condition

Patients with heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Inflammatory markers are closely associated with role of pathogenesis and adverse prognoses in patients with heart failure. C-reactive protein and PTX3, a novel inflammatory marker, predict adverse clinical outcomes in patient with heart failure. However, patients of those study were almost systolic heart failure. The relationship between inflammtory marker and left ventricular diastolic dysfunction are not clearly.
In the present study, we investigated the clinical significance of plasma PTX3 levels in patients with diastolic heart failure. Furthermore, because PTX3 reflects inflammatory status of local tissues, we investigated whether cardiac tissues produce PTX3.
Furthermore, we investigate whether plasma levels of PTX3 could predict occurrence of future cardiovascular events in patients with eart failure with normal ejection fraction.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The clinical significance of plasma PTX3 levels for patients with left ventricular diastolic dysfunction

Key secondary outcomes

cardiovascular events, which were a composite of CV death, non-fatal myocardial infarction or ischemic stroke, unstable angina, hospitalization for HF, or coronary revascularization.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with heart failure who are admitted to our hospital are enrolled. The diagnosis of heart failure is based on guidelines.
This study also enrolles control subjects in our hospital during the same enrollment period.

Key exclusion criteria

Exclusion criteria include active systemic inflammatory diseases, chronic renal failure requiring hemodialysis, active hepatic diseases, collagen diseases, presence of malignant tumor or acute coronary syndrome within 3 months preceding admission.

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Hisao Ogawa

Organization

Faculty of Life Sciences, Kumamoto University

Division name

Department of Cardiovascular Medicine

Zip code

Address

1-1-1 Honjo, Chuo-ku, Kumamoto City, Kumamoto, Japan

TEL

096-373-5175

Email

ogawah@kumamoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Junichi Matsubara

Organization

Faculty of Life Sciences, Kumamoto University

Division name

Department of Cardiovascular Medicine

Zip code

Address

1-1-1 Honjo, Chuo-ku, Kumamoto City, Kumamoto, Japan

TEL

096-373-5175

Homepage URL

Email

j-matsu@kumamoto-u.ac.jp

Institute

Graduate School of Medical Sciences, Kumamoto University

Institute

Department

Personal name

Organization

Self funding

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

Date of disclosure of the study information

2009

Year

07

Month

08

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

Completed

Date of protocol fixation

2006

Year

05

Month

01

Day

Date of IRB

Anticipated trial start date

2006

Year

06

Month

01

Day

Last follow-up date

2012

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Venous blood samples were obtained at the stable condition to measure levels of serum hs-CRP, plasma PTX3, BNP and other biochemical markers.
We also meseured levels of PTX3 at the aortic root and the coronary sinus within 2 minutes in patients who received coronary angiography.

Registered date

2009

Year

07

Month

08

Day

Last modified on

2013

Year

10

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002665