MADIT ASIA Cardiac Resynchronization Trial

Congestive Heart Failure Clinical Trial

— MADIT-ASIA  

Official title:

MADIT ASIA Cardiac Resynchronization Trial (MADIT-ASIA)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01872234
• Other study ID #: MADIT-ASIA
• Status: Terminated
• Phase: Phase 3
• First received: May 31, 2013
• Last updated: April 29, 2014
• Start date: February 2014
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationSingapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bundle-Branch Block
• Congestive Heart Failure
• Heart Block
• Heart Failure
• Heart Failure, Systolic
• Left Bundle Branch Block

Intervention

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.

Locations

Country	Name	City	State
China	Fu Wai Hospital	Beijing
China	Zhejiang hospital Hangzhou	Hangzhou
China	Grantham Hospital	Hong Kong	Hong Kong
China	Queen Mary Hospital	Hong Kong	Hong Kong
China	Zhongshan hospital Shanghai	Shanghai
China	Prince of Wales Hospital	Shatin	Hong Kong
India	Medanta-Medicity	Gurgaon	Haryana
India	CARE Hospital Nampally, Hyderabad	Hyderabad
India	Fortis Escorts Health Institute, New Delhi	New Delhi
Japan	Okayama University Hospital	Okayama
Japan	Tokyo Women's Medical Univesity Hospital	Shinjuku	Tokyo
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
Malaysia	Institut Jantung Negara	Kuala Lumpur
Singapore	National Heart Center	Singapore
Singapore	National University Heart Center Singapore	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
Taiwan	Chang Gung Memorial Hospital	Linkou
Thailand	Her Majesty's Cardiac Center, Siriraj Hospital, Mahidol University	Bangkok
Thailand	Ramathibodi Hospital, Mahidol University	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	University of Rochester

Countries where clinical trial is conducted

China,  India,  Japan,  Korea, Republic of,  Malaysia,  Singapore,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint	The primary endpoint will be the change in left ventricular ejection fraction (LVEF) from baseline to six months.	6 months post randomization	No
Secondary	All-cause mortality		6 months post randomization	Yes
Secondary	Recurrent heart failure or cardiovascular death, whichever comes first		6 months post randomization	No
Secondary	Changes in Left Ventricular End Systolic Volume (LVESV) and in Left Ventricular End Diastolic Volume (LVEDV)		6 months post randomization	No
Secondary	Change in NYHA functional class		6 months post randomization	No
Secondary	Atrial fibrillation events		6 months post randomization	No
Secondary	Change in left atrial size		6 months post randomization	No