Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-Induced Cardiomyopathy
Condition: Cardiomyopathy
MeSH terms: Cardiomyopathies
Study type: Interventional

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.
    

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 electrocardiographic depolarization duration (QRS) 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.
    

Intervention name(s): Three-lead CRT-D (Defibrillator)
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart failure; Chemotherapy-induced cardiomyopathy; Cardiac resynchronization therapy