search
Back to results

Effects of CRT Optimization as Assessed by Cardiac MR

Primary Purpose

Heart Failure, Systolic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Programming of CRT device settings
Sponsored by
Allina Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Systolic focused on measuring Cardiac Resynchronization Therapy, Pacing, Electrocardiography, Cardiac Magnetic Resonance Imaging, Echocardiography, Optimization of Cardiac Devices, Heart Failure

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Currently on standard medical therapy
  2. CRT device in place for > 4 months
  3. Non-responder (ejection fraction improvement with CRT < 5%) or incomplete responder (ejection fraction < 40%)
  4. Suboptimal electrical wavefront fusion at current CRT programming as observed on 12-lead ECG
  5. Left bundle branch block, interventricular conduction delay or right ventricular paced underlying QRS complex
  6. Age > 18 years

Exclusion Criteria:

  1. Decompensated heart failure
  2. Right bundle branch block
  3. Pregnancy or lactation
  4. History of severe allergic reactions to ECG gels, electrode adhesives, and/or cardiac magnetic resonance contrast (e.g. gadolinium)
  5. Implantation of pacing lead in the his bundle or left bundle branch
  6. Frequent ventricular ectopy as defined as >10% premature ventricular contraction burden by either device interrogation or Holter monitor, or sustained ventricular tachycardia/ventricular fibrillation
  7. Uncontrolled atrial fibrillation (HR > 100 bpm)
  8. Patient is enrolled in concurrent research study that would potentially confound the results of this study (noting: co-enrollment acceptable if patient is enrolled in registry study)

Sites / Locations

  • Minneapolis Heart Institute - Abbott Northwestern Hospital (MHI West)Recruiting
  • United Heart & Vascular Clinic - Nasseff Specialty Center (MHI East)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Baseline CRT programming

Electrocardiography-guided optimal CRT programming

Arm Description

The comparator arm patients will remain at baseline CRT programming for the first 6 months, and then will crossover to the experimental arm and CRT device will be programmed to optimal settings derived from the electrocardiographic assessment for the following 6 months.

The experimental arm patients will have CRT device programmed based on the electrocardiographic assessment for 12 months.

Outcomes

Primary Outcome Measures

Acute changes in left ventricular mechanical synchrony in study population
Acute changes, measured by cardiac magnetic resonance imaging, in left ventricular mechanical synchrony at underlying rhythm, baseline CRT programming, and optimal programming derived from electrocardiographic assessment in all patients.
Acute changes in left ventricular regional wall motion in study population
Acute changes, measured by cardiac magnetic resonance imaging, in left ventricular wall motion at underlying rhythm, baseline CRT programming, and optimal programming derived from electrocardiographic assessment in all patients.
Acute changes in left ventricular end-diastolic volume in study population
Acute changes, measured by cardiac magnetic resonance imaging, in left ventricular end-diastolic volume at underlying rhythm, baseline CRT programming, and optimal programming derived from electrocardiographic assessment in all patients.
Acute changes in left ventricular end-systolic volume in study population
Acute changes, measured by cardiac magnetic resonance imaging, in left ventricular end-systolic volume at underlying rhythm, baseline CRT programming, and optimal programming derived from electrocardiographic assessment in all patients.
Chronic changes in left ventricular mechanical synchrony
Chronic changes, measured by cardiac magnetic resonance imaging and echocardiography, in left ventricular mechanical synchrony between the experimental and active comparator group.
Chronic changes in left ventricular regional wall motion
Chronic changes, measured by cardiac magnetic resonance imaging and echocardiography, in left ventricular regional wall motion between the experimental and active comparator group.
Chronic changes in left ventricular end-diastolic volume
Chronic changes, measured by cardiac magnetic resonance imaging and echocardiography, in left ventricular end-diastolic volume between the experimental and active comparator group.
Chronic changes in left ventricular end-systolic volume
Chronic changes, measured by cardiac magnetic resonance and echocardiographic imaging, in left ventricular end-systolic volume between the experimental and active comparator group.

Secondary Outcome Measures

Change in 6 Minute Hall Walk (6MHW)
Comparison between experimental arm and active comparator arm in 6MHW
Change in Kansis City Cardiomyopathy Questionnaire (KCCQ)
Comparison between experimental arm and active comparator arm in KCCQ. Scores are scaled 0-100. Higher scores indicate better outcomes.

Full Information

First Posted
February 12, 2021
Last Updated
September 21, 2021
Sponsor
Allina Health System
Collaborators
Minneapolis Heart Institute Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT04763460
Brief Title
Effects of CRT Optimization as Assessed by Cardiac MR
Official Title
Effects of CRT Optimization on LV Mechanical Synchrony, Structure, and Function in CRT Patients as Assessed by Cardiac MR
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allina Health System
Collaborators
Minneapolis Heart Institute Foundation

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
No

5. Study Description

Brief Summary
Cardiac resynchronization therapy (CRT), or atrial-synchronized biventricular (BiV) pacing, is an FDA-approved device therapy option for heart failure (HF) patients with reduced left ventricular ejection fraction and electrical dyssynchrony. A traditional CRT device has pacing leads implanted within the right atrium (RA), the right ventricle (RV), and within a coronary vein overlying the lateral or posterior left ventricle (LV). Within the past decade, various multi-center randomized controlled trials have reported improved quality of life, aerobic exercise capacity, LV systolic function and structure, as well as decreased hospitalization rates and mortality among patients with HF. Despite improvements in CRT technology with multipoint pacing, quadripolar leads, and adaptive pacing algorithms, approximately 30% of patients do not clinically benefit and are considered non-responders. This study looks to optimize CRT device programming in patients considered non-responders to CRTusing information obtained from standard ECG machines, and to assess acute and chronic effects of CRT optimization using cardiac magnetic resonance imaging (CMR).
Detailed Description
This is a prospective, randomized study designed to evaluate if CRT device optimization, guided by electrocardiography, improves cardiac function and clinical outcomes among patients considered non-responders to CRT. All patients will have electrocardiographic assessment of electrical dyssynchrony at a range of device settings using standard ECG machines. All patients will then have a baseline CMR study at baseline CRT programming, underlying rhythm, and optimal settings derived from the electrocardiographic assessment to assess acute effects of CRT optimization on mechanical synchrony, LV regional wall motion, and LV structure/ function. To assess chronic effects of CRT optimization, patients will be randomized in a 1:1 ratio after baseline CMR to either the active comparator arm (baseline CRT programming), or the experimental arm (CRT device programmed to optimal settings derived from the electrocardiographic assessment). Patients will be blinded to randomization. After 6 month, all patients will return for follow up CMR study to assess chronic effects. After follow up CMR imaging, the active comparator group will crossover to the experimental group. After 12 months, all patients will return for follow up echocardiogram to further evaluate the chronic effects of CRT optimization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic
Keywords
Cardiac Resynchronization Therapy, Pacing, Electrocardiography, Cardiac Magnetic Resonance Imaging, Echocardiography, Optimization of Cardiac Devices, Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel (with 6 month crossover) 1:1 randomization - active comparator and experimental arm (note: at 6 month, the active comparator arm will crossover to the experimental arm)
Masking
ParticipantOutcomes Assessor
Masking Description
Patients blinded to which group they are randomized and how their CRT device is programmed during the study. Individuals (readers) who perform cardiac magnetic resonance and echocardiographic imaging measurements blinded to patient randomization and CRT programming.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baseline CRT programming
Arm Type
Active Comparator
Arm Description
The comparator arm patients will remain at baseline CRT programming for the first 6 months, and then will crossover to the experimental arm and CRT device will be programmed to optimal settings derived from the electrocardiographic assessment for the following 6 months.
Arm Title
Electrocardiography-guided optimal CRT programming
Arm Type
Experimental
Arm Description
The experimental arm patients will have CRT device programmed based on the electrocardiographic assessment for 12 months.
Intervention Type
Device
Intervention Name(s)
Programming of CRT device settings
Intervention Description
Reprogramming of CRT device to maximize the benefit derived from the electrocardiographic assessment.
Primary Outcome Measure Information:
Title
Acute changes in left ventricular mechanical synchrony in study population
Description
Acute changes, measured by cardiac magnetic resonance imaging, in left ventricular mechanical synchrony at underlying rhythm, baseline CRT programming, and optimal programming derived from electrocardiographic assessment in all patients.
Time Frame
During Baseline Assessment
Title
Acute changes in left ventricular regional wall motion in study population
Description
Acute changes, measured by cardiac magnetic resonance imaging, in left ventricular wall motion at underlying rhythm, baseline CRT programming, and optimal programming derived from electrocardiographic assessment in all patients.
Time Frame
During Baseline Assessment
Title
Acute changes in left ventricular end-diastolic volume in study population
Description
Acute changes, measured by cardiac magnetic resonance imaging, in left ventricular end-diastolic volume at underlying rhythm, baseline CRT programming, and optimal programming derived from electrocardiographic assessment in all patients.
Time Frame
During Baseline Assessment
Title
Acute changes in left ventricular end-systolic volume in study population
Description
Acute changes, measured by cardiac magnetic resonance imaging, in left ventricular end-systolic volume at underlying rhythm, baseline CRT programming, and optimal programming derived from electrocardiographic assessment in all patients.
Time Frame
During Baseline Assessment
Title
Chronic changes in left ventricular mechanical synchrony
Description
Chronic changes, measured by cardiac magnetic resonance imaging and echocardiography, in left ventricular mechanical synchrony between the experimental and active comparator group.
Time Frame
Baseline to 12 months
Title
Chronic changes in left ventricular regional wall motion
Description
Chronic changes, measured by cardiac magnetic resonance imaging and echocardiography, in left ventricular regional wall motion between the experimental and active comparator group.
Time Frame
Baseline to 12 months
Title
Chronic changes in left ventricular end-diastolic volume
Description
Chronic changes, measured by cardiac magnetic resonance imaging and echocardiography, in left ventricular end-diastolic volume between the experimental and active comparator group.
Time Frame
Baseline to 12 months
Title
Chronic changes in left ventricular end-systolic volume
Description
Chronic changes, measured by cardiac magnetic resonance and echocardiographic imaging, in left ventricular end-systolic volume between the experimental and active comparator group.
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Change in 6 Minute Hall Walk (6MHW)
Description
Comparison between experimental arm and active comparator arm in 6MHW
Time Frame
Baseline to 12 months
Title
Change in Kansis City Cardiomyopathy Questionnaire (KCCQ)
Description
Comparison between experimental arm and active comparator arm in KCCQ. Scores are scaled 0-100. Higher scores indicate better outcomes.
Time Frame
Baseline to 12 months
Other Pre-specified Outcome Measures:
Title
Correlation in electrical dyssynchrony and left ventricular function in study population
Description
Changes in electrical dyssynchrony, measured by electrocardiography, and correlation to change in left ventricular function, measured by cardiac magnetic resonance and echocardiographic imaging, in all patients.
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Currently on standard medical therapy CRT device in place for > 4 months Non-responder (ejection fraction improvement with CRT < 5%) or incomplete responder (ejection fraction < 40%) Suboptimal electrical wavefront fusion at current CRT programming as observed on 12-lead ECG Left bundle branch block, interventricular conduction delay or right ventricular paced underlying QRS complex Age > 18 years Exclusion Criteria: Decompensated heart failure Right bundle branch block Pregnancy or lactation History of severe allergic reactions to ECG gels, electrode adhesives, and/or cardiac magnetic resonance contrast (e.g. gadolinium) Implantation of pacing lead in the his bundle or left bundle branch Frequent ventricular ectopy as defined as >10% premature ventricular contraction burden by either device interrogation or Holter monitor, or sustained ventricular tachycardia/ventricular fibrillation Uncontrolled atrial fibrillation (HR > 100 bpm) Patient is enrolled in concurrent research study that would potentially confound the results of this study (noting: co-enrollment acceptable if patient is enrolled in registry study)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher D Brown
Phone
651-241-2806
Email
christopher.brown2@allina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan J Bank, MD
Organizational Affiliation
Allina Heath System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis Heart Institute - Abbott Northwestern Hospital (MHI West)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher D Brown
Phone
651-241-2806
Email
christopher.brown2@allina.com
First Name & Middle Initial & Last Name & Degree
João L Cavalcante, MD
First Name & Middle Initial & Last Name & Degree
Jay D Sengupta, MD
Facility Name
United Heart & Vascular Clinic - Nasseff Specialty Center (MHI East)
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher D Brown
Phone
651-241-2806
Email
christopher.brown2@allina.com
First Name & Middle Initial & Last Name & Degree
Alan J Bank, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share IPD with other external researchers.

Learn more about this trial

Effects of CRT Optimization as Assessed by Cardiac MR

We'll reach out to this number within 24 hrs