Clinical Trial: Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-Induced Cardiomyopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-Induced Cardiomyopathy

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.

Detailed Summary:

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 s
Sponsor: University of Rochester

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Effects of CRT on all-cause mortality [ Time Frame: 6 months post implant ]
    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 ]
    Determine based on echocardiogram study if CRT therapy improves left ventricular volume at end systole and end diastole between baseline and six months


Original Secondary Outcome: Same as current

Information By: University of Rochester

Dates:
Date Received: June 12, 2014
Date Started: November 2014
Date Completion: July 2017
Last Updated: August 25, 2016
Last Verified: August 2016