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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 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: August 25, 2016
Last verified: August 2016
  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 30 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: 30
Study Start Date: November 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (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 months to 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 10-15 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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Without clinical heart failure at initiation of chemotherapy/radiation-induced treatment for an underlying malignancy, but developed clinical heart failure (cardiomyopathy: reduced LVEF with a LBBB-type of conduction disturbance; see next inclusion item) 6 months or more after initiation of the chemotherapy without other evident cause of the cardiomyopathy.
  • 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
  • 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
  • Cardiac condition not presumed to be caused by chemotherapy
  • Documented symptoms or hemodynamically unstable ventricular tachyarrhythmia
  • On active chemotherapy (must be at least 6 calendar months after last chemotherapy)
  • Permanent or chronic AF (atrial fibrillation), or cardioversion for AF within the past 3 calendar months before consent date
  • Structural heart disease such as congenital heart disease, valvular heart disease, e.g., rheumatic valvular heart disease, amyloid heart disease, etc.
  • Coronary artery bypass graft surgery or percutaneous coronary intervention within the past 3 calendar months before consent date
  • 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
  • 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
  • Class IV and expected to undergo transplant within study duration
  • Current or past history of drug addiction or abuse that caused cardiomyopathy
  • Pregnant or plans to become pregnant during the course of the trial.
  • Recent cerebral vascular accident or transient ischemia attack within the previous 3 months prior to consent date
  • 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.
  • Participating in any other clinical trial
  • Unwilling or unable to cooperate with the protocol
  • Lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult
  • Does not anticipate being a resident of the area for the scheduled duration of the trial
  • Unwilling to sign the consent for participation
  • 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, California
UCLA Cardiovascular Center Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Eric H Yang, MD    310-825-9011    ehyang@mednet.ucla.edu   
Principal Investigator: Eric H Yang, MD         
United States, District of Columbia
MedStar Washington Hospital Center 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 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
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jagmeet Singh, MD    617-726-4662    jsingh@partners.org   
Principal Investigator: Jagmeet Singh, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Anju Nohria, MD    617-525-6852    anohria@partners.org   
Principal Investigator: Anju Nohria, MD         
United States, Missouri
Washington University 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
New York Presbyterian Hospita/Columbia University Medical Center 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 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, Ohio
University Hospitals Case Medical Center 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 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 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

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: August 25, 2016
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
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 02, 2016