UMIN-CTR Clinical Trial

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

Hyperuricemic CHF patients with preserved ejection fraction

Classification by specialty

Cardiology

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nippon Medical School Hospital

Institute

Department

Personal name

Organization

SANWA KAGAKU KENKYUSHO CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

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

2016

Year

11

Month

24

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

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 related information

Registered date

2016

Year

11

Month

24

Day

Last modified on

2019

Year

07

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028746