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

20. Februar 2020 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: CRT-D (Defibrillator)
Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Left Ventricular Ejection Fraction
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With All-Cause Mortality
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in New York Heart Association (NYHA) Functional Class
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Rochester

Mitarbeiter

Boston Scientific Corporation

Ermittler

  • Hauptermittler: Valentina Kutyifa, MD, PhD, University of Rochester

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2014

Primärer Abschluss (Tatsächlich)

6. Februar 2019

Studienabschluss (Tatsächlich)

6. Februar 2019

Studienanmeldedaten

Zuerst eingereicht

12. Juni 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Juni 2014

Zuerst gepostet (Schätzen)

17. Juni 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. März 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Februar 2020

Zuletzt verifiziert

1. Februar 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MADIT-CHIC

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