UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007846
Receipt number R000009245
Scientific Title Reserch on the effect of losartan on diastolic heart failure patients with hyperuricemia
Date of disclosure of the study information 2012/05/01
Last modified on 2012/04/27 13:50:47

* 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

Reserch on the effect of losartan on diastolic heart failure patients with hyperuricemia

Acronym

Losartan study

Scientific Title

Reserch on the effect of losartan on diastolic heart failure patients with hyperuricemia

Scientific Title:Acronym

Losartan study

Region

Japan


Condition

Condition

Elderly diastolic heart failure patients with hyperuricemia

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison between the effect of ACE-inhibitor and losartan on elderly diastolic heart failure patients with hyperuricemia in terms of uric acid level and diastolic dysfunction

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of uric acid level

Key secondary outcomes

1.NYHA
2.Rho-kinase activity of circulating leukocyte
3.cyclophilin A, 8-isoproatane
4.pentraxin3, Hs-CRP
5.NT-proBNP
6.renin activity, aldsterone activity
7.echocardiography: ejection fraction, diastolic function(E/A,E/e')
8.flow mediated dilation
9.urinary albumin-to-creatinine ratio
10.Hospitalization for worsenig heart failure,all cause death


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Losartan(12 week)

Interventions/Control_2

ACE-inhibitor(12 week)

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

65 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

65 years old or over
Hypertension
Undertreatment of ACE inhibitor
Serum uric acid level 7.0mg/dl or over

Key exclusion criteria

Medication for high uric acid
Creatinine level 2.0mg/dl or over
Serum potassium level 5.0meq/l or over
Clinical history of Gouty attack
Undertreatment of angiotensin receptor blocker
NYHA4

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jun Takahashi

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code


Address

1-1,Seiryo-machi, Aoba-ku,Sendai

TEL

022-717-7153

Email



Public contact

Name of contact person

1st name
Middle name
Last name Tsuyoshi Takada

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code


Address

1-1,Seiryo-machi, Aoba-ku,Sendai

TEL

022-717-7153

Homepage URL


Email

takada006@cardio.med.tohoku.ac.jp


Sponsor or person

Institute

Losartan study group

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine

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

東北大学病院(宮城県)


Other administrative information

Date of disclosure of the study information

2012 Year 05 Month 01 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

Preinitiation

Date of protocol fixation

2012 Year 04 Month 17 Day

Date of IRB


Anticipated trial start date

2012 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 04 Month 27 Day

Last modified on

2012 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009245


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name