MADIT ASIA Cardiac Resynchronization Trial

NCT01872234 | Terminated Phase 3 DMC

• 1 other identifier: MADIT-ASIA
• Study Type: interventional
• Target: 1
• Locations: 8 countries
• Sites: 21

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.

Conditions

Congestive Heart Failure; Left Bundle Branch Block; Heart Failure, Systolic

Keywords

Heart Failure; Cardiac Resynchronization Therapy; Mild systolic dysfunction; Left Bundle Branch Block

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  The primary endpoint will be the change in left ventricular ejection fraction (LVEF) from baseline to six months.

  6 months post randomization

Secondary Outcomes (6)

• All-cause mortality

  6 months post randomization

• Recurrent heart failure or cardiovascular death, whichever comes first

  6 months post randomization

• Changes in Left Ventricular End Systolic Volume (LVESV) and in Left Ventricular End Diastolic Volume (LVEDV)

  6 months post randomization

• Change in NYHA functional class

  6 months post randomization

• Atrial fibrillation events

  6 months post randomization

Study Arms (2)

Device Arm: Two Lead CRT-P

EXPERIMENTAL

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

Control: Optimal Pharmacologic Therapy

NO INTERVENTION

The control group will be managed on optimal pharmacologic therapy only. They will not be implanted with a device.

Interventions

Two-lead CRT-P DEVICE

The two lead CRT-P will consist of a dual chamber pacemaker, a right atrial lead and a left ventricular lead.

Device Arm: Two Lead CRT-P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• University of Rochester: collaborator

Study Sites (21)

Grantham Hospital

Hong Kong, Hong Kong, China

Location

Queen Mary Hospital

Hong Kong, Hong Kong, China

Location

Prince of Wales Hospital

Shatin, Hong Kong, China

Location

Fu Wai Hospital

Beijing, China

Location

Zhejiang hospital Hangzhou

Hangzhou, China

Location

Zhongshan hospital Shanghai

Shanghai, China

Location

Medanta-Medicity

Gurgaon, Haryana, India

Location

Fortis Escorts Health Institute, New Delhi

New Delhi, New Delhi, India

Location

CARE Hospital Nampally, Hyderabad

Hyderabad, India

Location

Tokyo Women's Medical Univesity Hospital

Shinjuku, Tokyo, Japan

Location

Okayama University Hospital

Okayama, Japan

Location

Institut Jantung Negara

Kuala Lumpur, Malaysia

Location

National Heart Center

Singapore, Singapore

Location

National University Heart Center Singapore

Singapore, Singapore

Location

Tan Tock Seng Hospital

Singapore, Singapore

Location

Korea University Medical Center

Seoul, South Korea

Location

Seoul ASAN Medical Center

Seoul, South Korea

Location

Yonsei University Medical Center - Severance Hospital

Seoul, South Korea

Location

Chang Gung Memorial Hospital

Linkou District, Taiwan

Location

Her Majesty's Cardiac Center, Siriraj Hospital, Mahidol University

Bangkok, Thailand

Location

Ramathibodi Hospital, Mahidol University

Bangkok, Thailand

Location

MeSH Terms

Conditions

Heart Failure; Bundle-Branch Block; Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arthur J. Moss, M.D.

  Univ. of Rochester Medical Center, Rochester, New York 14642, heartajm@heart.rochester.edu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 7, 2013
• Study Start: February 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 30, 2014

Record last verified: 2014-04

Locations

MY (1); SG (3); TH (2); JP (2); KR (3); IN (3); TW (1); CN (6)