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

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ClinicalTrials.gov Identifier: NCT02164721
Recruitment Status : Completed
First Posted : June 17, 2014
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Valentina Kutyifa, University of Rochester

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiomyopathy Device: Three-lead CRT-D (Defibrillator) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-Induced Cardiomyopathy
Study Start Date : November 2014
Actual Primary Completion Date : February 6, 2019
Actual Study Completion Date : February 6, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in Left Ventricular Ejection Fraction [ Time Frame: 6 months post implant ]
    The primary endpoint will be the change in left ventricular ejection fraction (LVEF) from baseline to six months


Secondary Outcome Measures :
  1. Effects of CRT on all-cause mortality [ Time Frame: 6 months post implant ]
    Determine the effects of CRT on all-cause mortality

  2. Effects of CRT therapy on left ventricular volume at end systole and end diastole [ Time Frame: 6 months post implant ]
    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:
  1. Change in NYHA (New York Heart Association) functional class [ Time Frame: 6 months post implant ]
    Change in NYHA functional class between baseline and six months

  2. Change in left atrial size [ Time Frame: 6 months post implant ]
    Change in left atrial size between baseline and six months

  3. Effects of CRT on frequency of heart failure [ Time Frame: 6 months post implant ]
    Effects of CRT on the frequency of heart failure with end point of inpatient hospitalization with augmented treatment for heart failure



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164721


Locations
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United States, California
UCLA Cardiovascular Center
Los Angeles, California, United States, 90095
United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of South Florida
Tampa, Florida, United States, 33606
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
New York Presbyterian Hospita/Columbia University Medical Center
New York, New York, United States, 10032
Univeristy of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
University of Rochester
Boston Scientific Corporation
Investigators
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Principal Investigator: Valentina Kutyifa, MD, PhD University of Rochester

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Responsible Party: Valentina Kutyifa, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT02164721     History of Changes
Other Study ID Numbers: MADIT-CHIC
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019

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

Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases