Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades

Chronic Systolic Heart Failure Clinical Trial

Official title:

Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03504891
• Other study ID #: MRI FOR CRT UPGRADES
• Status: Recruiting
• Phase: Phase 1
• Start date: January 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: April 2018
• Source: University of Virginia
• Contact: Kenneth C Bilchick, MD
• Phone: 434-924-2465
• Email: bilchick[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Systolic Heart Failure
• Heart Failure
• Heart Failure, Systolic
• Paroxysmal VT

Intervention

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.
• MRI prior to de novo CRT
We will perform MRI prior to de novo CRT implants as the comparison group.

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRT Response	CRT Response Based on Change in LVESV After CRT	6 months
Secondary	Improvement in Peak Oxygen Consumption	Peak VO2	6 months
Secondary	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