NCT02164721

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 4, 2020

Completed
Last Updated

March 4, 2020

Status Verified

February 1, 2020

Enrollment Period

4.3 years

First QC Date

June 12, 2014

Results QC Date

January 24, 2020

Last Update Submit

February 20, 2020

Conditions

Cardiomyopathy

Keywords

Heart failureChemotherapy-induced cardiomyopathyCardiac resynchronization therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Left Ventricular Ejection Fraction

    The primary endpoint will be the change in left ventricular ejection fraction (LVEF) from baseline to six months

    6 months post implant

Secondary Outcomes (3)

  • Number of Participants With All-Cause Mortality

    6 months post implant

  • Effects of CRT Therapy on Left Ventricular Volume at End Diastole

    6 months post implant

  • Effects of CRT Therapy on Left Ventricular Volume at End Systole

    6 months post implant

Other Outcomes (3)

  • Change in New York Heart Association (NYHA) Functional Class

    6 months post implant

  • Change in Left Atrial Size

    6 months post implant

  • Effects of CRT on Frequency of Heart Failure

    6 months post implant

Study Arms (1)

CRT-D (Defibrillator)

OTHER

Implantation of a three-lead CRT-D (Defibrillator) in all registered patients

Device: Three-lead CRT-D (Defibrillator)

Interventions

Three-lead CRT-D (Defibrillator)DEVICE

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.

CRT-D (Defibrillator)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Eligible for implantation of a CRT-D (cardiac resynchronization therapy-defibrillator) device according to one of the following options in currently available guidelines:
  • 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
  • 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
  • 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.

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

UCLA Cardiovascular Center

Los Angeles, California, 90095, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

New York Presbyterian Hospita/Columbia University Medical Center

New York, New York, 10032, United States

Location

Univeristy of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Singh JP, Solomon SD, Fradley MG, Barac A, Kremer KA, Beck CA, Brown MW, McNitt S, Schleede S, Zareba W, Goldenberg I, Kutyifa V; MADIT-CHIC Investigators. Association of Cardiac Resynchronization Therapy With Change in Left Ventricular Ejection Fraction in Patients With Chemotherapy-Induced Cardiomyopathy. JAMA. 2019 Nov 12;322(18):1799-1805. doi: 10.1001/jama.2019.16658.

    PMID: 31714987DERIVED

MeSH Terms

Conditions

CardiomyopathiesHeart Failure

Interventions

Defibrillators

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ElectrodesElectrical Equipment and SuppliesEquipment and Supplies

Limitations and Caveats

The findings are limited by the small sample size, short follow-up, and absence of a control group.

Results Point of Contact

Title
Valentina Kutyifa MD, PhD
Organization
University of Rochester
valentina.kutyifa@heart.rochester.edu
585-275-2676

Study Officials

  • Valentina Kutyifa, MD, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 17, 2014

Study Start

November 1, 2014

Primary Completion

February 6, 2019

Study Completion

February 6, 2019

Last Updated

March 4, 2020

Results First Posted

March 4, 2020

Record last verified: 2020-02

Locations

US(9)