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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024981
Receipt No. R000028746
Scientific Title Suggestion Of Using topiroxostat for a Group of Hyperuricemic CHF patients with preserved ejection fraction for better Treatment outcomes study (SOUGHT study)
Date of disclosure of the study information 2016/11/24
Last modified on 2019/07/17

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Basic information
Public title Suggestion Of Using topiroxostat for a Group of Hyperuricemic CHF patients with preserved ejection fraction for better Treatment outcomes study (SOUGHT study)
Acronym Suggestion Of Using topiroxostat for a Group of Hyperuricemic CHF patients with preserved ejection fraction for better Treatment outcomes study (SOUGHT study)
Scientific Title Suggestion Of Using topiroxostat for a Group of Hyperuricemic CHF patients with preserved ejection fraction for better Treatment outcomes study (SOUGHT study)
Scientific Title:Acronym Suggestion Of Using topiroxostat for a Group of Hyperuricemic CHF patients with preserved ejection fraction for better Treatment outcomes study (SOUGHT study)
Region
Japan

Condition
Condition Hyperuricemic CHF patients with preserved ejection fraction
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to evaluate heart function in hyperuricemic patients complicated with HFpEF of NYHA classes II to IV after initiating topiroxostat
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percent change of BNP from baseline to the 24th week
Key secondary outcomes Values and changes of the following items (1) to (6) at each observation point

(1) Uric acid evaluation (serum uric acid level, XOR activity, hypoxanthine, xanthine)

(2) Heart function (BNP, NT-proBNP, troponin T, hs-CRP, CTR, LVEF [the Teichholz method, and the modified Simpson method], LVEDV, LVESV, LVDd, LVDs, LVMI, E/E', E/A, DcT, left atrial dimension (LAD), LA area, TAPSE, TRPG)

(3) Vascular endothelium function (using Endo-PAT)

(4) Oxidative stress marker, vascular endothelium marker, etc. (ADMA, ICAM-I, VEGF, IL-6, MMP-2, MMP-9, MDA-LDL, dROMs, urinary 8-OHdG)

(5) Renal function (BUN, Cr, e-GFR, cystatin C, urinary L-FABP)

(6) General blood test items, body weight, BMI, blood pressure, pulse

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
Medicine
Interventions/Control_1 Methods of administering topiroxostat
<Increase amount of topiroxostat>
Orally take topiroxostat twice a day; morning and night. Aiming serum uric acid level 6.0mg/dL or lower, the amount of the study drug has to be increased in order from (1) to (2) and to (3) as stated below. When uric acid level 6.0mg/dL or lower is achieved, the patient is continuously observed with the dose (3). Increasing the dose from (3) to (4) is only for those patients who are unable to achieve the target serum uric acid. If the patient shows gouty arthritis on the day planning to initiate or increase topiroxostat, do not administer the study drug.

[Dosage]
(1) 40mg/day, (2) 80mg/day, (3) 120mg/day, and (4) 160mg/day

<Decrease amount of topiroxostat>
After initiating topiroxostat, if serum uric acid went below 3.0mg/dL, the dosage before current one must be prescribed.
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
85 years-old >
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria are included in this study.

1. Patients who are at age of 20 or older and younger than age of 80 at the time of consenting

2. Patients with gout or hyperuricemia at the time of consenting

3. Patients who have not taken medication for hyperuricemia within 12 weeks before consenting

4. Patients with CHF classified as NYHA II to IV and LVEF is 50% or more

5. Patients with stable heart failure (NYHA class is stable, and medication for heart function has stayed the same within 4 weeks before consenting)

6. Patients who are capable of giving their consent in a written form
Key exclusion criteria Patients who fall into any of the following criteria are excluded from participating in the study.

1. Patients who have a medical history of hypersensitivity to topiroxostat, febuxostat, or allopurinol

(2) Patients who are currently using mercaptopurine hydrate, or planning to use it

(3) Patients who are currently using azathioprine, or planning to use it

(4) Patients who are going to have coronary artery bypass or revascularization within 6 months

(5) Patients with malignancy (except those who are completely cured)*

(6) Patients whose ALT and AST are doubled or more from the standard levels of the institution

(7) Patients with chronic hepatitis B or C, and classified active

(8) Patients complicated with hepatic cirrhosis*

(9) Patients with eGFR 30mL/min/1.73m2 or below and show renal function impairment

(10) Patients with other conditions that the attending physician thinks inappropriate to participate in this study

* It is based on the decision of their physicians
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wataru Shimizu
Organization Nippon Medical School Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Email kasai@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Takayama
Organization Soiken Inc.
Division name Clinical Study Support Division
Zip code
Address NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL 03-3295-1350
Homepage URL
Email takayama@soiken.com

Sponsor
Institute Nippon Medical School Hospital
Institute
Department

Funding Source
Organization SANWA KAGAKU KENKYUSHO 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
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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 24 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 Completed
Date of protocol fixation
2016 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 04 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
2016 Year 11 Month 24 Day
Last modified on
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028746

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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