Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Systolic Heart Failure; Paroxysmal VT
• Intervention / Treatment: Diagnostic test: MRI prior to CRT Upgrade; Diagnostic test: MRI prior to de novo 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kenneth C Bilchick, MD; Phone Number: 434-924-2465; Email: bilchick@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22901
      • Recruiting
      • University of Virginia Health System
      • Contact: Kenneth C Bilchick, MD; Phone Number: 434-924-2465; Email: bilchick@virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRT Response	CRT Response Based on Change in LVESV After CRT	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Peak Oxygen Consumption	Peak VO2	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Kenneth C Bilchick, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Systolic
• Other Study ID Numbers: MRI FOR CRT UPGRADES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• 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