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Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-Induced Cardiomyopathy (MADIT-CHIC)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University of Rochester
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Arthur J. Moss, University of Rochester
ClinicalTrials.gov Identifier:
NCT02164721
First received: June 12, 2014
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

The purpose of this trial or study is to determine if cardiac resynchronization therapy (CRT) can be a benefit to people who have impaired heart function due to past treatment with chemotherapy and/or chest radiation. The investigators are looking to enroll approximately 100 eligible subjects with heart failure in this trial. All patients enrolled and registered in the study will be implanted with a cardiac resynchronization therapy device that includes an implantable cardiac defibrillator (CRT-D). 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. Following implantation of the CRT-D, patients will be contacted by phone at 3 months and will have a scheduled clinic visit follow-up at 6 months.


Condition Intervention
Cardiomyopathy
Device: Three-lead CRT-D (Defibrillator)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-Induced Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Change in Left Ventricular Ejection Fraction [ Time Frame: 6 months post implant ] [ Designated as safety issue: No ]
    The primary endpoint will be the change in left ventricular ejection fraction (LVEF) from baseline to six months


Secondary Outcome Measures:
  • Effects of CRT on all-cause mortality [ Time Frame: 6 months post implant ] [ Designated as safety issue: Yes ]
    Determine the effects of CRT on all-cause mortality

  • Effects of CRT therapy on left ventricular volume at end systole and end diastole [ Time Frame: 6 months post implant ] [ Designated as safety issue: No ]
    Determine based on echocardiogram study if CRT therapy improves left ventricular volume at end systole and end diastole between baseline and six months


Other Outcome Measures:
  • Change in NYHA (New York Heart Association) functional class [ Time Frame: 6 months post implant ] [ Designated as safety issue: No ]
    Change in NYHA functional class between baseline and six months

  • Change in left atrial size [ Time Frame: 6 months post implant ] [ Designated as safety issue: No ]
    Change in left atrial size between baseline and six months

  • Effects of CRT on frequency of heart failure [ Time Frame: 6 months post implant ] [ Designated as safety issue: Yes ]
    Effects of CRT on the frequency of heart failure with end point of inpatient hospitalization with augmented treatment for heart failure


Estimated Enrollment: 100
Study Start Date: July 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CRT-D (Defibrillator)
Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
Device: Three-lead CRT-D (Defibrillator)
The three-lead CRT-D (Defibrillator) will consist of a pulse generator, a right atrial lead, a right ventricular lead and a left ventricular lead.

Detailed Description:

With the advent of new therapies and an increasing number of long-term cancer survivors, the incidence and consequently the interest in chemotherapy-induced cardiomyopathy (CHIC) have been increasing. CHIC is a dose-dependent cardiomyopathy and presents as congestive heart failure several years after the administration of chemotherapy and/or chest radiation that includes the heart.

Greater than one-half of the patients exposed to just this class of drugs will show evidence of cardiac dysfunction, with 5% presenting with overt symptomatic heart failure. The overall incidence of CHIC is significantly underestimated as within the US alone, greater than 60,000 patients receive just anthracyclines every year. Despite this, there is little data on their response to conventional heart failure therapy. There is some preliminary evidence from two small, retrospective case-series suggesting that patients with CHIC and evidence of conduction tissue disease (i.e. a wide QRS duration) may significantly benefit from cardiac resynchronization therapy (CRT).

MADIT-CHIC is a multicenter, non-randomized, prospective observational study. The primary aim is to determine if CRT-D (Defibrillator) in high-risk patients with chemotherapy-induced cardiomyopathy will significantly improve left ventricular ejection fraction (LVEF) by echocardiography within 6 months of initiating CRT without adversely affecting mortality.

The study will last 6 months and will be conducted in 12-20 clinical centers in the United States.

Following implantation of the CRT-D device (Defibrillator), patients will be followed for 6 months. The first follow-up contact will be by phone at which time study personnel will review the patient's health status. The last study contact will be a 6-month clinic visit. At the 6-month visit, the patient's health status will be reviewed, the functioning of the CRT-D (Defibrillator) will be tested and an echocardiogram will be conducted. After the 6-month visit, the study-required follow-up will have been completed and patients will continue to have CRT-D (Defibrillator) clinical follow-up based on their physicians direction.

During the course of the study, Subjects will as outlined in the inclusion criteria continue 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, Angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blocker (ARB), Aldosterone antagonists and/or Beta-blockers unless the subject is not indicated, contraindicated, or is intolerant of medication.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is age 18 (or of legal age to give informed consent specific to state and national law) up to 80 years of age
  • Male or Female
  • Subject eligible for implantation of a CRT-D device according to one of the following options in currently available guidelines:

    1. Class 1: LVEF less than or equal to 35% AND sinus rhythm AND LBBB (left bundle branch block) with a QRS (electrocardiographic depolarization duration) duration greater than or equal to 150ms AND NYHA (New York Heart Association) class II, III or ambulatory IV symptoms on guideline-directed medical therapy
    2. Class 2a1: LVEF less than or equal to 35% AND sinus rhythm AND LBBB with a QRS duration 120-149ms AND NYHA class II, III or ambulatory IV symptoms on guideline-directed medical therapy
    3. Class 2a2: LVEF less than or equal to 35% AND sinus rhythm AND Non-LBBB with a QRS duration greater than or equal to 150ms AND NYHA class III or ambulatory IV symptoms on guideline-directed medical therapy
  • 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, Angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blocker (ARB), Aldosterone antagonists and/or Beta-blockers unless the subject is not indicated, contraindicated, or is intolerant of medication.

Exclusion Criteria:

  • Currently implanted pacemaker or implantable cardioverter defibrillator (ICD) device
  • Previous implant with a CRT/CRT-D device
  • Documented symptoms or hemodynamically unstable ventricular tachyarrhythmia
  • Subjects on active chemotherapy (must be at least 2 calendar years after last chemotherapy)
  • Permanent or chronic AF (atrial fibrillation), or cardioversion for AF within the past 3 calendar months before consent date
  • 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 consent date
  • Subject with enzyme positive myocardial infarction within the past 3 calendar months prior to consent date
  • Unstable angina requiring hospitalization, with diagnostic work up and intervention within the past 3 months prior to consent date
  • 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
  • Subject in Class IV and expected to undergo transplant within study duration
  • Current or past history of drug addiction or abuse that caused cardiomyopathy
  • 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 consent date
  • Subject with recent CVA (cerebral vascular accident) or TIA (transient ischemia attack) within the previous 3 months prior to consent date
  • Subject with presence of any disease, other than the subject's cardiac or cancer disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., uremia, liver failure, active malignant disease, etc.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02164721

Contacts
Contact: Kristina A Kremer, BSN 585-275-5264 kris.kremer@heart.rochester.edu
Contact: Mary W Brown, MS 585-275-8823 mary.brown@heart.rochester.edu

Locations
United States, District of Columbia
MedStar Washington Hospital Center Not yet recruiting
Washington, District of Columbia, United States, 20010
Contact: Ana Barac, MD    202-877-2162    ana.barac@medstar.net   
Principal Investigator: Ana Barac, MD         
United States, Florida
University of South Florida Not yet recruiting
Tampa, Florida, United States, 33606
Contact: Michael Fradley, MD    813-259-8543    mfradley@health.usf.edu   
Principal Investigator: Michael Fradley, MD         
United States, Massachusetts
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Anju Nohria, MD    617-525-6852    anohria@partners.org   
Principal Investigator: Anju Nohria, MD         
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Sanjeev Francis, MD    617-726-9230    SAFRANCIS@PARTNERS.ORG   
Principal Investigator: Sanjeev Francis, MD         
United States, Missouri
Washington University Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Ronald Krone, MD    314-747-4450    rkrone@dom.wustl.edu   
Principal Investigator: Ronald Krone, MD         
United States, New York
Icahn School of Medicine at Mount Sinai Not yet recruiting
New York, New York, United States, 10029
Contact: Marie-Noelle Langan, MD    212-744-2345    marie-noelle.langan@mountsinai.org   
Principal Investigator: Marie-Noelle Langan, MD         
New York Presbyterian Hospita/Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact: Greg Rosner, MD    212-342-3820    grosner@columbia.edu   
Principal Investigator: Greg Rosner, MD         
Univeristy of Rochester Medical Center Not yet recruiting
Rochester, New York, United States, 14642
Contact: Eugene Storozynsky, MD    585-273-3760    Eugene.Storozynsky@urmc.rochester.edu   
Principal Investigator: Eugene Storozynsky, MD         
United States, North Carolina
Duke University Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Camille Frazier-Mills, MD    919-668-2688    camille.frazier@duke.edu   
Principal Investigator: Camille Frazier-Mills, MD         
United States, Ohio
University Hospitals Case Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Guilherme Oliveira, MD       guilherme.oliveira@uhhospitals.org   
Principal Investigator: Guilherme Oliveira, MD         
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: David Lenihan, MD    615-936-0335    daniel.lenihan@vanderbilt.edu   
Principal Investigator: David Lenihan, MD         
United States, Texas
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Edward T. Yeh, MD    713-792-1960    ethyeh@mdanderson.org   
Principal Investigator: Edward T. Yeh, MD         
Sponsors and Collaborators
University of Rochester
Boston Scientific Corporation
Investigators
Principal Investigator: Arthur J Moss, MD University of Rochester
  More Information

No publications provided

Responsible Party: Arthur J. Moss, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT02164721     History of Changes
Other Study ID Numbers: MADIT-CHIC
Study First Received: June 12, 2014
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Rochester:
Heart failure
Chemotherapy-induced cardiomyopathy
Cardiac resynchronization therapy

Additional relevant MeSH terms:
Cardiomyopathies
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 24, 2014