UMIN-CTR Clinical Trial

Public title

Japan working group on The effects of ARBs Selection (Azilsartan vs. Candesartan) on diastolic function in The patients suffering from heart failure with preserved Ejection fraction

Acronym

Japan working group on The effects of ARBs Selection (Azilsartan vs. Candesartan) on diastolic function in The patients suffering from heart failure with preserved Ejection fraction (J-TASTE trial)

Scientific Title

Japan working group on The effects of ARBs Selection (Azilsartan vs. Candesartan) on diastolic function in The patients suffering from heart failure with preserved Ejection fraction

Scientific Title:Acronym

Japan working group on The effects of ARBs Selection (Azilsartan vs. Candesartan) on diastolic function in The patients suffering from heart failure with preserved Ejection fraction (J-TASTE trial)

Region

Japan

Condition

Heart failure with left ventricular diastolic dysfunction complicating hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the effects of the treatment of azilsartan with those of candesartan on left ventricular diastolic function in a multicenter, randomized, open-label, evaluator-blinded, active-controlled, parallel-group, exploratory study in patients with heart failure with left ventricular diastolic dysfunction complicating hypertension

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The change in E/e' assessed by echocardiography (from baseline to the end of the study)

Key secondary outcomes

Evaluation for LV diastolic function improvement assessed by echocardiography except for E/e' change

The change in
1) e' from baseline (at the end of the study)
2) E/A from baseline (at the end of the study)
3) deceleration time of E from baseline (at the end of the study)
4) LAD from baseline (at the end of the study)

Evaluation for cardiac structure, systolic and diastolic function assessed by echocardiography
5) LVDd, LVDs, LAVI, and LAD
6) LVEF from baseline (at the end of the study)
7) LVMI from baseline (at the end of the study)
8) the end-systolic elastance and end-diastolic elastance of the LV from baseline (at the end of the study)

Evaluation for heart failure severity
9) NYHA functional classification from baseline (24-week post drug administration and the end of the study)
10) NT-proBNP levels from baseline (4-week post drug administration and the end of the study)
11) serum aldosteron levels from baseline (at the end of the study)

Evaluation for antihypertensive effect
12) systolic and diastolic blood pressure from baseline (4, 12, 24, 36-week post drug administration and at the end of the study)

Evaluation for cardiovascular event

The incidence of
13) composite end point (death from cardiovascular disease or hospitalization for cardiovascular disease) at the end of the study
14) composite end point (death from cardiovascular disease or hospitalization for heart failure) at the end of the study
15) death from cardiovascular disease (at the end of the study)
16) hospitalization for cardiovascular disease (at the end of the study)
17) hospitalization for heart failure (at the end of the study)
18) death from any cause (at the end of the study)
19) hospitalization for any cause (at the end of the study)
20) additional therapy or dose escalation for heart failure caused by worsening of heart failure (24-week post drug administration and the end of the study)
21) onset of new atrial fibrillation/flutter (at the end of the study)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Azilsartan group
Administration of 20 mg azilsartan once daily

Patients who have already received azilsartan should continue the same dose at the time of consent. Patients who have received other ARB medications should be administered the ARB-quivalent dose of azilsartane. Patients who have received combination drugs including ARB should be individually administered the ARB-equivalent dose of azilsartan and the other antihypertensive components.
Patients are observed for their tolerability and safety a month after administration and azilsartan can be increased to 40 mg once daily if the antihypertensive effect is considered insufficient according to Guidelines for the Management of Hypertension. Azilsartan can be decreased to 10 mg once daily when patients feel lightheadedness with an excessive antihypertensive effect.
Patients are then observed for their blood pressure controls at each visit, and azilsartan can be increased depending on their doses if the antihypertensive effect is considered insufficient. Patients who have been received azilsartan 40 mg once daily can be treated with antihypertensives other than ARB if the effect is considered insufficient. When patients feel lightheadedness with an excessive antihypertensive effect, azilsartan can be decreased or discontinued depending on their doses. The administration period is one year.

Interventions/Control_2

Candesartan group
Administration of 8 mg candesartan once daily (starting with 2 mg once daily when eGFR < 30)

Patients who have already received candesartan should continue the same dose at the time of consent. Patients who have received other ARB medications should be administered the ARB-equivalent dose of candesartan. Patients who have received combination drugs including ARB should be individually administered the ARB-equivalent dose of candesartan and the other antihypertensive components.
Patients are observed for their tolerability and safety a month after administration and the dose can be adjusted according to Guidelines for the Management of Hypertension.
Candesartan can be increased depending on the doses used if the antihypertensive effect is considered insufficient. Patients who have been received candesartan 12 mg once daily can be treated with antihypertensives other than ARB if the effect is considered insufficient. When patients feel lightheadedness with an excessive antihypertensive effect, candesartan can be decreased or discontinued depending on their doses. The administration period is one year.

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

1) 20-85 years of age at consent
2) Patients with hypertension within 3 months from the date of obtaining consent
Patients who satisfy any of the following conditions are considered hypertensive:
1. Patients with newly-diagnosed hypertension
2. Untreated patients with hypertension
3. Patients receiving an antihypertensive for hypertension
3) BNP levels >= 40 pg/mL or NT-proBNP levels >= 125 pg/mL, at least once within 4 months prior to the date of obtaining consent
4) Patients with heart failure
Patients who satisfy any of the following conditions are considered heart failure:
1. Patients being hospitalized for heart failure
2. Patients with history of hospitalization for heart failure
3. NYHA functional classification >= II
5) Patients whose left ventricular ejection fraction >= 45% assessed by echocardiography within 4 months from the date of consent
6) Patients with left ventricular diastolic function ( E/e' >= 8) assessed by echocardiography
7) provided written informed consent

Key exclusion criteria

1) Patients with history of adverse reactions including hyperkalemia or severe renal dysfunction by receiving ARB before consent
2) Patients receiving ACE inhibitor at consent
3) Patients with persistent atrial fibrillation at consent (not including a history of treatment for atrial fibrillation or presence of paroxysmal atrial fibrillation)
4) Systolic blood pressure remains continuously < 90 mmHg
5) Using mechanical ventricular assist device
6) Waiting for heart transplantation
7) Waiting for cardiac surgery
8) Patients with valvular heart disease at a moderate level or higher (except for moderate functional mitral regurgitation)
9) Patients underwent mitral valve replacement or mitral annuloplasty
10) Patients underwent constrictive pericarditis
11) Patients with a definitive diagnosis of hypertrophic cardiomyopathy
12) Patients with hyperkalemia at screening (equal or higher than 5.5 mEq/l)
13) Patients with serious renal dysfunction (eGFR < 15 mL/min/1.73 m²) at screening
14) Patients with hepatic dysfunction (elevation in AST/ALT levels 3 times greater than the upper limit of normal) at screening (When the elevation is attributable to the heart disease, the patient is eligible if the total bilirubin level is less than 3.0 mg/dL)
15) Patients with a history of hospitalization for cerebrovascular disorder within 6 months before consent
16) Patients with bilateral renal artery stenosis or patients who have only one kidney with artery stenosis
17) Patients with history of hypersensitivity to drug
18) Patients who have less than 3 years of life expectancy due to serious disease
19) Patients suspected of alcohol or drug abuse
20) Patients with diabetes receiving aliskiren fumarate
21) Pregnant or possibility of pregnancy
22) Patients who are participating in another study (except for observational research)
23) Patients considered ineligible to participate in this study by principal (sub) investigator

Target sample size

190

Name of lead principal investigator

1st name	Masafumi
Middle name
Last name	Kitakaze

Organization

National Cerebral and Cardiovascular Center

Division name

Department of Clinical Medicine and Development

Zip code

564-8565

Address

6-1 Kishibe-Shimmachi, Suita, Osaka

TEL

06-6170-1070

Email

kitakaze@zf6.so-net.ne.jp

Name of contact person

1st name	Shin
Middle name
Last name	Ito

Organization

National Cerebral and Cardiovascular Center

Division name

Department of Cardiovascular Medicine

Zip code

564-8565

Address

6-1 Kishibe-Shimmachi, Suita, Osaka

TEL

06-6170-1070

Homepage URL

Email

taste.trial@ml.ncvc.go.jp

Institute

National Cerebral and Cardiovascular Center

Institute

Department

Personal name

Organization

Takeda Pharmaceutical Company Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Certified Review Board of Hyogo College of Medicine

Address

1-1 Mukogawa-cho, Nishinomiya City, Hyogo

Tel

0798-45-6066

Email

rinken@hyo-med.ac.jp

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

05

Month

31

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

No longer recruiting

Date of protocol fixation

2015

Year

12

Month

07

Day

Date of IRB

2015

Year

12

Month

18

Day

Anticipated trial start date

2016

Year

06

Month

01

Day

Last follow-up date

2020

Year

07

Month

07

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered in jRCT.
The number of clinical trial plan:jRCTs051180137

Registered date

2016

Year

05

Month

31

Day

Last modified on

2022

Year

01

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025995