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Congestive Heart FailurePhase 3MADIT-ASIANCT01872234

MADIT ASIA Cardiac Resynchronization Trial

A Phase 3 study testing Two-lead CRT-P in people with Congestive Heart Failure and Left Bundle Branch Block, run by Boston Scientific Corporation at 21 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Two-lead CRT-P
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
21 sitesin 8 countries
Study dates
Feb 2014to Apr 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

21 sites in 8 countries.

21 sites in 8 countries

China6 sites

  • Fu Wai Hospital

    Beijing

  • Zhejiang hospital Hangzhou

    Hangzhou

  • Grantham Hospital

    Hong Kong, Hong Kong

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Zhongshan hospital Shanghai

    Shanghai

  • Prince of Wales Hospital

    Shatin, Hong Kong

Other trials in China

India3 sites

  • Medanta-Medicity

    Gurgaon, Haryana

  • CARE Hospital Nampally, Hyderabad

    Hyderabad

  • Fortis Escorts Health Institute, New Delhi

    New Delhi, New Delhi

Other trials in India

Singapore3 sites

  • National Heart Center

    Singapore

  • National University Heart Center Singapore

    Singapore

  • Tan Tock Seng Hospital

    Singapore

Other trials in Singapore

South Korea3 sites

  • Korea University Medical Center

    Seoul

  • Seoul ASAN Medical Center

    Seoul

  • Yonsei University Medical Center - Severance Hospital

    Seoul

Other trials in South Korea

Japan2 sites

  • Okayama University Hospital

    Okayama

  • Tokyo Women's Medical Univesity Hospital

    Shinjuku, Tokyo

Other trials in Japan

Thailand2 sites

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

    Bangkok

  • Ramathibodi Hospital, Mahidol University

    Bangkok

Other trials in Thailand

Malaysia1 site

  • Institut Jantung Negara

    Kuala Lumpur

Other trials in Malaysia

Taiwan1 site

  • Chang Gung Memorial Hospital

    Linkou District

Other trials in Taiwan

About this study

Official title: MADIT ASIA Cardiac Resynchronization Trial (MADIT-ASIA)

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.

Read the 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.

Being tested
Two-lead CRT-P
Keywords
Heart Failure, Cardiac Resynchronization Therapy, Mild systolic dysfunction, Left Bundle Branch Block
Medical subject headings
Heart Failure, Bundle-Branch Block, Heart Failure, Systolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Two-lead CRT-PDevice

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

Study groups in NCT01872234
Study groupRoleWhat they receive
Device Arm: Two Lead CRT-PExperimentalIntervention: 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.
Receives: Device: Two-lead CRT-P
Control: Optimal Pharmacologic TherapyNo interventionThe control group will be managed on optimal pharmacologic therapy only. They will not be implanted with a device.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Endpoint

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

    Measured: 6 months post randomization

Secondary outcomes (6)

  1. All-cause mortality

    Measured: 6 months post randomization

  2. Recurrent heart failure or cardiovascular death, whichever comes first

    Measured: 6 months post randomization

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

    Measured: 6 months post randomization

  4. Change in NYHA functional class

    Measured: 6 months post randomization

  5. Atrial fibrillation events

    Measured: 6 months post randomization

  6. Change in left atrial size

    Measured: 6 months post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2013 (estimated)
  2. Study startFeb 2014
  3. Primary completionApr 2014
  4. Study completionApr 2014

Why it stopped: The study encountered significant difficulties in patient enrollment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01872234
Sponsor's protocol ID
MADIT-ASIA
Acronym
MADIT-ASIA
Status last verified
Apr 2014
First submitted
31 May 2013
Last updated
30 Apr 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Two-lead CRT-P in people with Congestive Heart Failure and Left Bundle Branch Block, run by Boston Scientific Corporation at 21 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in China, India, Singapore, South Korea, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study encountered significant difficulties in patient enrollment.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint (time frame: 6 months post randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01872234.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2014.

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