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Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades

Primary Purpose

Chronic Systolic Heart Failure, Paroxysmal VT

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MRI prior to CRT Upgrade
MRI prior to de novo CRT
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Systolic Heart Failure

Eligibility Criteria

25 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Undergoing upgrade from an existing pacemaker or ICD to a CRT device.

Exclusion Criteria:

  • inability to provide informed consent
  • pregnancy
  • presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
  • cerebral aneurysm clips
  • cochlear implants
  • other metallic implants known to be contraindications to MRI (pacemakers and ICDs are allowed)
  • severe claustrophobia
  • acute kidney injury
  • acute renal failure
  • gadolinium allergy
  • abandoned leads

Sites / Locations

  • University of Virginia Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MRI Prior to CRT for Upgrades

MRI Prior to de novo CRT Implants

Arm Description

MRI will be performed prior to CRT upgrade.

MRI will be performed prior to de novo CRT implants.

Outcomes

Primary Outcome Measures

CRT Response
CRT Response Based on Change in LVESV After CRT

Secondary Outcome Measures

Improvement in Peak Oxygen Consumption
Peak VO2
Improvement in Short Form (36) Health Survey
Assesses disability associated with heart failure. We will use the total score, which has a range of 0-100. Lower scores indicate greater disability.

Full Information

First Posted
April 12, 2018
Last Updated
April 30, 2018
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT03504891
Brief Title
Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades
Official Title
Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will investigate the use of cardiac MRI in patients with standard ICDs and pacemakers to inform how cardiac resynchronization therapy (CRT) can best be implemented in these patient and which patients are the best candidates for CRT.
Detailed Description
The scientific premise of this proposal is that left and right ventricular (LV and RV) structural characteristics in patients with existing cardiac implantable electronic devices and heart failure who may benefit from an upgrade to a cardiac resynchronization therapy (CRT) device can be assessed very effectively using cardiac MRI using sequences designed for post-device imaging. Furthermore, a comparative analysis of the differences in LV/RV structural characteristics in patients with existing devices referred for CRT upgrades versus those with de novo CRT implants is expected to be very useful for developing effective strategies for optimal patient selection for CRT upgrades and implementation of CRT upgrades in appropriate patients. Patient selection for CRT upgrades is very important considering that complication rates are higher than in de novo CRT procedures and nonresponse rates are still high. With this in mind, we are performing a study of 100 patients, including 50 prospectively enrolled patients with LVEF less than or equal to 0.35 and New York Heart Association class II-III heart failure, who will be compared with an existing cohort of 50 patients with recent de novo CRT implants, pre-CRT MRIs, and response data. The 50 prospectively enrolled patients having CRT upgrades will undergo a pre-CRT cardiac MRI, pre-CRT/post-CRT echocardiography, and pre-CRT/post-CRT cardiopulmonary exercise testing. In the first aim, we will assess differences in cardiac MRI findings between CRT upgrade patients and de novo CRT patients. In the second aim, we will assess the impact of cardiac MRI findings on LV reverse remodeling and cardiopulmonary capacity in the two groups. In summary, we propose a comprehensive prospective CRT/MRI study in CRT upgrade patients with comparison to a complete MRI dataset of patients with de novo CRT implants in order to identify key differences in MRI findings in these cohorts and the impact of these MRI-based scar and activation findings on clinical outcomes. We expect that our results will have a significant public health impact for patients with heart failure referred for CRT upgrades.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Systolic Heart Failure, Paroxysmal VT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Patients will have cardiac MRI prior to CRT.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRI Prior to CRT for Upgrades
Arm Type
Experimental
Arm Description
MRI will be performed prior to CRT upgrade.
Arm Title
MRI Prior to de novo CRT Implants
Arm Type
Active Comparator
Arm Description
MRI will be performed prior to de novo CRT implants.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI prior to CRT Upgrade
Intervention Description
We will perform MRI prior to CRT to inform the optimal CRT implantation strategy in patients with existing devices undergoing upgrades versus those with de novo CRT implants. We will compare outcomes in the two groups.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI prior to de novo CRT
Intervention Description
We will perform MRI prior to de novo CRT implants as the comparison group.
Primary Outcome Measure Information:
Title
CRT Response
Description
CRT Response Based on Change in LVESV After CRT
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement in Peak Oxygen Consumption
Description
Peak VO2
Time Frame
6 months
Title
Improvement in Short Form (36) Health Survey
Description
Assesses disability associated with heart failure. We will use the total score, which has a range of 0-100. Lower scores indicate greater disability.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Undergoing upgrade from an existing pacemaker or ICD to a CRT device. Exclusion Criteria: inability to provide informed consent pregnancy presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging cerebral aneurysm clips cochlear implants other metallic implants known to be contraindications to MRI (pacemakers and ICDs are allowed) severe claustrophobia acute kidney injury acute renal failure gadolinium allergy abandoned leads
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth C Bilchick, MD
Phone
434-924-2465
Email
bilchick@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth C Bilchick, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth C Bilchick, MD
Phone
434-924-2465
Email
bilchick@virginia.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
This research will generate MRI, echocardiographic, and cardiopulmonary exercise data in patients referred for CRT upgrades. Examples of specific data fields include the extent/distribution of myocardial scar based on late gadolinium enhancement, characterization of mechanical activation based on MRI strain imaging, baseline MRI volumetric and functional measures, changes in echocardiographic volumes and function resulting from CRT, and changes in cardiopulmonary capacity resulting from CRT.
IPD Sharing Time Frame
2 years
IPD Sharing Access Criteria
Not yet available.

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Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades

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