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

20 février 2020 mis à jour par: Valentina Kutyifa, University of Rochester
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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • California
      • Los Angeles, California, États-Unis, 90095
        • UCLA Cardiovascular Center
    • District of Columbia
      • Washington, District of Columbia, États-Unis, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Tampa, Florida, États-Unis, 33606
        • University of South Florida
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02114
        • Massachusetts General Hospital
    • Missouri
      • Saint Louis, Missouri, États-Unis, 63110
        • Washington University
    • New York
      • New York, New York, États-Unis, 10032
        • New York Presbyterian Hospita/Columbia University Medical Center
      • Rochester, New York, États-Unis, 14642
        • Univeristy of Rochester Medical Center
    • Tennessee
      • Nashville, Tennessee, États-Unis, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, États-Unis, 77030
        • MD Anderson Cancer Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 left ventricular ejection fraction (LVEF) with a left bundle branch block (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 (cardiac resynchronization therapy-defibrillator) device according to one of the following options in currently available guidelines:

    1. Class 1: Left ventricular ejection fraction (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: Left ventricular ejection fraction (LVEF) less than or equal to 35% AND sinus rhythm AND left bundle branch block (LBBB) with a QRS (electrocardiographic depolarization duration) duration 120-149ms AND New York Heart Classification (NYHA) class II, III or ambulatory IV symptoms on guideline-directed medical therapy
    3. Class 2a2: Left ventricular ejection fraction (LVEF) less than or equal to 35% AND sinus rhythm AND Non-left bundle branch block (LBBB) with a QRS(electrocardiographic depolarization duration) duration greater than or equal to 150ms AND New York Heart Classification (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 (cardiac resynchronization therapy)/CRT-D (cardiac resynchronization therapy-defibrillator) 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 Atrial Fibrillation (AF), 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: CRT-D (Defibrillator)
Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Left Ventricular Ejection Fraction
Délai: 6 months post implant
The primary endpoint will be the change in left ventricular ejection fraction (LVEF) from baseline to six months
6 months post implant

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Participants With All-Cause Mortality
Délai: 6 months post implant
Number of Participants with All-Cause Mortality in CRT-D patients
6 months post implant
Effects of CRT Therapy on Left Ventricular Volume at End Diastole
Délai: 6 months post implant
Determine based on echocardiogram study if CRT therapy improves left ventricular volume at end diastole (LVEDV) between baseline and six months
6 months post implant
Effects of CRT Therapy on Left Ventricular Volume at End Systole
Délai: 6 months post implant
Determine based on echocardiogram study if CRT therapy improves left ventricular volume at end systole (LVESV) between baseline and six months
6 months post implant

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Change in New York Heart Association (NYHA) Functional Class
Délai: 6 months post implant
Improvement in NYHA functional class between baseline and six months (yes/no), ie. change from NYHA class III to NYHA II.
6 months post implant
Change in Left Atrial Size
Délai: 6 months post implant
Change in left atrial size between baseline and six months
6 months post implant
Effects of CRT on Frequency of Heart Failure
Délai: 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
6 months post implant

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Rochester

Collaborateurs

Boston Scientific Corporation

Les enquêteurs

  • Chercheur principal: Valentina Kutyifa, MD, PhD, University of Rochester

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 novembre 2014

Achèvement primaire (Réel)

6 février 2019

Achèvement de l'étude (Réel)

6 février 2019

Dates d'inscription aux études

Première soumission

12 juin 2014

Première soumission répondant aux critères de contrôle qualité

16 juin 2014

Première publication (Estimation)

17 juin 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 mars 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 février 2020

Dernière vérification

1 février 2020

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • MADIT-CHIC

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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