UMIN-CTR Clinical Trial

Public title

MADIT ASIA
Cardiac Resynchronization Trial

Acronym

MADIT-ASIA

Scientific Title

MADIT ASIA
Cardiac Resynchronization Trial

Scientific Title:Acronym

MADIT-ASIA

Region

Japan

Asia(except Japan)

Condition

high-risk cardiac patients with a recent hospitalization for overt heart failure and a moderately preserved ejection fraction

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The primary objective of this trial is to determine whether a two-lead CRT-P system will significantly improve echo-determined left ventricular ejection fraction between baseline and 6 months of two-lead CRT-P therapy in high-risk cardiac patients with a recent hospitalization for overt heart failure and a moderately preserved ejection fraction.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Significantly greater improvement in echo-determined LVEF when compared to optimal pharmacologic therapy between baseline and 6 months in high-risk cardiac patients with a recent hospitalization for overt heart failure.

Key secondary outcomes

All-cause mortality, rates of recurrent heart failure and cardiovascular death (whichever comes first), changes in LVESV and LVEDV, NYHA functional class, effect of two-lead CRT-P therapy in ischemic vs. non ischemic patients with heart failure, occurrence of atrial fibrillation events, effects of two lead CRT-P on left atrial size.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

1. Optimal Pharmacologic Therapy and Two Lead CRT-P

Interventions/Control_2

2. Optimal Pharmacologic Therapy

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

Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
Hospitalization for heart failure using the Framingham criteria requiring medical treatment more than 4 weeks ago but less than six months prior to randomization date
Subject in sinus rhythm
Subject with QRS duration =>110 milliseconds and left bundle branch block or incomplete left bundle branch block
Subject with ejection fraction 36-50%
Subject with ischemic or non-ischemic heart disease
Subject on stable* optimal pharmacologic therapy for the cardiac condition that is guideline-based and may include one or more of the following medications: Loop diuretics (e.g., furosemide, bumetanide, torsemide) unless the subject is not indicated, is contraindicated, or is intolerant of loop diuretics; Angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blocker (ARB) unless the subject failed, is not indicated, or is contraindicated for these therapies; Aldosterone antagonists unless the subject is not indicated, or is intolerant of aldosterone antagonists; Beta-blockers unless the subject is not indicated, contraindicated, or is intolerant of beta-blockers. The choice of selective or non-selective beta-blockers use is left to the Investigator's discretion
* For purposes of the study, "stable" is defined as beta blockers and ACE/ARB for at least three months prior to randomization, unless contraindicated or not tolerated, with stable doses for at least one month prior to randomization. It is permissible for diuretic and aldosterone antagonist dosage to have been adjusted as necessary.

Key exclusion criteria

Subject with:
- A currently implanted pacemaker, ICD, CRT-P or CRT-D generator or device component
-A history of spontaneous sustained VT=>160 bpm or VF
-Permanent or chronic AF, or cardioversion for AF within the past 3 calendar months before randomization
-Structural heart disease such as congenital heart disease, valvular heart disease, e.g., rheumatic valvular heart disease, amyloid heart disease, etc.
-Coronary artery bypass graft surgery or percutaneous coronary intervention within the past 3 calendar months before randomization
-Enzyme positive myocardial infarction within the past 3 calendar months prior to randomization
-Angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future
-Second or third degree heart block
-Irreversible brain damage from pre-existing cerebral disease
-Presence of any disease, other than the subject's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, liver failure, etc.
-Chronic renal disease with blood urea nitrogen (BUN) =>50mg/dl (18 mmol/l) or creatinine => 2.5mg/dl (221 µmol/l)
Right bundle branch block or non-specific interventricular conduction delay
Subject in New York Heart Association Class IV
Subject who is pregnant or plans to become pregnant during the course of the trial. Note: Women of childbearing potential must have a negative pregnancy test within 7 days prior to randomization
Subject participating in any other clinical trial
Subject unwilling or unable to cooperate with the protocol
Subject who lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult
Subject who does not anticipate being a resident of the area for the scheduled duration of the trial
Subject unwilling to sign the consent for participation
Subject whose physician does not allow participation

Target sample size

180

Name of lead principal investigator

1st name
Middle name
Last name	Arthur J. Moss

Organization

University of Rochester

Division name

University of Rochester Medical Center

Zip code

Address

265 Crittenden Blvd, CPU Box 420653

TEL

585-275-5391

Email

arthur.moss@heart.rochester.edu

Name of contact person

1st name
Middle name
Last name	Shoda Morio

Organization

Tokyo Women's Medical University

Division name

Department of Cardiology

Zip code

Address

8-1,Kawadacho,Shinjuku-Ku,Tokyo

TEL

03-3353-8111

Homepage URL

Email

mshoda@hij.twmu.ac.jp

Institute

University of Rochester

Institute

Department

Personal name

Organization

Boston Scientific Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

The United States

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

NCT01872234

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京女子医科大学病院(東京都)、岡山大学病院(岡山県)、東京大学医学部附属病院(東京都)

Date of disclosure of the study information

2013

Year

09

Month

20

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

Terminated

Date of protocol fixation

2012

Year

10

Month

23

Day

Date of IRB

Anticipated trial start date

2014

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

09

Month

03

Day

Last modified on

2014

Year

05

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013569