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Recruitment status Terminated
Unique ID issued by UMIN UMIN000011640
Receipt No. R000013569
Scientific Title MADIT ASIA Cardiac Resynchronization Trial
Date of disclosure of the study information 2013/09/20
Last modified on 2014/05/12

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Basic information
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
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

Objectives
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

Assessment
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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
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

Intervention
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
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 &micro;mol/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

Research contact person
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

Public contact
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

Sponsor
Institute University of Rochester
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Boston Scientific Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization The United States

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
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
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)

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 20 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 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
Other related information

Management information
Registered date
2013 Year 09 Month 03 Day
Last modified on
2014 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013569


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