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Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades

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ClinicalTrials.gov Identifier: NCT03504891
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Kenneth Bilchick, MD, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Chronic Systolic Heart Failure Paroxysmal VT Diagnostic Test: MRI prior to CRT Upgrade Diagnostic Test: MRI prior to de novo CRT Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will have cardiac MRI prior to CRT.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: MRI Prior to CRT for Upgrades
MRI will be performed prior to CRT upgrade.
Diagnostic Test: MRI prior to CRT Upgrade
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.

Active Comparator: MRI Prior to de novo CRT Implants
MRI will be performed prior to de novo CRT implants.
Diagnostic Test: MRI prior to de novo CRT
We will perform MRI prior to de novo CRT implants as the comparison group.




Primary Outcome Measures :
  1. CRT Response [ Time Frame: 6 months ]
    CRT Response Based on Change in LVESV After CRT


Secondary Outcome Measures :
  1. Improvement in Peak Oxygen Consumption [ Time Frame: 6 months ]
    Peak VO2

  2. Improvement in Short Form (36) Health Survey [ Time Frame: 6 months ]
    Assesses disability associated with heart failure. We will use the total score, which has a range of 0-100. Lower scores indicate greater disability.



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Ages Eligible for Study:   25 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504891


Contacts
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Contact: Kenneth C Bilchick, MD 434-924-2465 bilchick@virginia.edu

Locations
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United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22901
Contact: Kenneth C Bilchick, MD    434-924-2465    bilchick@virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Kenneth C Bilchick, MD University of Virginia

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Responsible Party: Kenneth Bilchick, MD, Associate Professor of Medicine, University of Virginia
ClinicalTrials.gov Identifier: NCT03504891     History of Changes
Other Study ID Numbers: MRI FOR CRT UPGRADES
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: 2 years
Access Criteria: Not yet available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases