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MADIT ASIA Cardiac Resynchronization Trial (MADIT-ASIA)

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ClinicalTrials.gov Identifier: NCT01872234
Recruitment Status : Terminated (The study encountered significant difficulties in patient enrollment.)
First Posted : June 7, 2013
Last Update Posted : April 30, 2014
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
The purpose of this trial or study is to determine if pacemaker therapy can be a beneficial alternative to conventional medical therapy in patients with a history of moderate heart failure. The investigators are looking to enroll approximately 180 people in this trial. Patients will be randomized in two groups. One group will be implanted with a pacemaker and will continue to receive conventional medical therapy as prescribed by their doctor. The second group will continue to receive conventional medical therapy as prescribed by their doctor and will not be implanted with a pacemaker. Clinical histories, physical exams, and external device testing will be collected both at the time of enrollment in the trial and during follow-up study visits. Patients who enter the study will be seen for study visits at 1 month, 3 and 6 months.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Left Bundle Branch Block Heart Failure, Systolic Device: Two-lead CRT-P Phase 3

Detailed Description:

MADIT-ASIA is a multicenter, prospective, randomized clinical study. The primary aim is to show that two lead CRT-P with guideline-based optimal pharmacological therapy is associated with a significantly greater improvement in left ventricular ejection fraction (LVEF) at 6 months compared with guideline-based optimal pharmacologic therapy only.

The study will be initially conducted at approximately 25 centers in up to 9 countries in Asia including India, Thailand, Taiwan, Malaysia, China, Japan, South Korea and Singapore. If necessary, more sites may be invited to participate to meet the enrollment goal.

Following randomization, subjects will have scheduled clinic visit follow-ups at 1, 3 and 6-month intervals. Relevant event history, cardiac medications, physical assessment, device interrogation/programming status and adverse events will be collected at each follow-up visit. At the 6-month visit, a repeat echocardiogram and a 12-lead ECG will be obtained. Subjects will be followed through the 6 month visit. After that, subjects will have a safety follow up contact at the end of the study. The study will end when the last randomized subject reaches the 6 months visit.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MADIT ASIA Cardiac Resynchronization Trial (MADIT-ASIA)
Study Start Date : February 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Device Arm: Two Lead CRT-P
Intervention: Device: Two-lead CRT-P. Patients will be implanted with a two lead CRT-P system: right atrial lead, left ventricular lead and a dual chamber pacemaker. Patients in this group will also be under optimal pharmacologic therapy.
Device: Two-lead CRT-P
The two lead CRT-P will consist of a dual chamber pacemaker, a right atrial lead and a left ventricular lead.

No Intervention: Control: Optimal Pharmacologic Therapy
The control group will be managed on optimal pharmacologic therapy only. They will not be implanted with a device.



Primary Outcome Measures :
  1. Primary Endpoint [ Time Frame: 6 months post randomization ]
    The primary endpoint will be the change in left ventricular ejection fraction (LVEF) from baseline to six months.


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 6 months post randomization ]
  2. Recurrent heart failure or cardiovascular death, whichever comes first [ Time Frame: 6 months post randomization ]
  3. Changes in Left Ventricular End Systolic Volume (LVESV) and in Left Ventricular End Diastolic Volume (LVEDV) [ Time Frame: 6 months post randomization ]
  4. Change in NYHA functional class [ Time Frame: 6 months post randomization ]
  5. Atrial fibrillation events [ Time Frame: 6 months post randomization ]
  6. Change in left atrial size [ Time Frame: 6 months post randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  • Subject with a currently implanted pacemaker, ICD, CRT-P or CRT-D generator or device component
  • Subject with a history of spontaneous sustained VT>160 bpm or VF
  • Subject with permanent or chronic AF, or cardioversion for AF within the past 3 calendar months before randomization
  • Subject with structural heart disease such as congenital heart disease, valvular heart disease, e.g., rheumatic valvular heart disease, amyloid heart disease, etc.
  • Subject with coronary artery bypass graft surgery or percutaneous coronary intervention within the past 3 calendar months before randomization
  • Subject with enzyme positive myocardial infarction within the past 3 calendar months prior to randomization
  • Subject with 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
  • Right bundle branch block or non-specific interventricular conduction delay
  • Subject with second or third degree heart block
  • Subject in New York Heart Association Class IV (symptoms of heart failure at rest)
  • 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 with irreversible brain damage from pre-existing cerebral disease
  • Subject with 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, uremia, liver failure, etc.
  • Subject with chronic renal disease with blood urea nitrogen (BUN) > 50mg/dl (18 mmol/l) or creatinine > 2.5mg/dl (221 µmol/l)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872234


Locations
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China, Hong Kong
Grantham Hospital
Hong Kong, Hong Kong, China
Queen Mary Hospital
Hong Kong, Hong Kong, China
Prince of Wales Hospital
Shatin, Hong Kong, China
China
Fu Wai Hospital
Beijing, China
Zhejiang hospital Hangzhou
Hangzhou, China
Zhongshan hospital Shanghai
Shanghai, China
India
Medanta-Medicity
Gurgaon, Haryana, India
CARE Hospital Nampally, Hyderabad
Hyderabad, India
Fortis Escorts Health Institute, New Delhi
New Delhi, India
Japan
Tokyo Women's Medical Univesity Hospital
Shinjuku, Tokyo, Japan
Okayama University Hospital
Okayama, Japan
Korea, Republic of
Korea University Medical Center
Seoul, Korea, Republic of
Seoul ASAN Medical Center
Seoul, Korea, Republic of
Yonsei University Medical Center - Severance Hospital
Seoul, Korea, Republic of
Malaysia
Institut Jantung Negara
Kuala Lumpur, Malaysia
Singapore
National Heart Center
Singapore, Singapore
National University Heart Center Singapore
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
Taiwan
Chang Gung Memorial Hospital
Linkou, Taiwan
Thailand
Her Majesty's Cardiac Center, Siriraj Hospital, Mahidol University
Bangkok, Thailand
Ramathibodi Hospital, Mahidol University
Bangkok, Thailand
Sponsors and Collaborators
Boston Scientific Corporation
University of Rochester
Investigators
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Principal Investigator: Arthur J. Moss, M.D. Univ. of Rochester Medical Center, Rochester, New York 14642, heartajm@heart.rochester.edu

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01872234     History of Changes
Other Study ID Numbers: MADIT-ASIA
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: April 30, 2014
Last Verified: April 2014
Keywords provided by Boston Scientific Corporation:
Heart Failure
Cardiac Resynchronization Therapy
Mild systolic dysfunction
Left Bundle Branch Block
Additional relevant MeSH terms:
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Heart Failure
Bundle-Branch Block
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Heart Block
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes