Clinical trial NCT04763460: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure, Systolic
Keywords: Cardiac Resynchronization Therapy
Pacing
Electrocardiography
Cardiac Magnetic Resonance Imaging
Echocardiography
Optimization of Cardiac Devices
Heart Failure
Lead sponsor: Allina Health System
Sponsor class: OTHER
Collaborators: name: Minneapolis Heart Institute Foundation
First posted: 2021-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Acute changes in left ventricular mechanical synchrony in study population
timeFrame: During Baseline Assessment
measure: Acute changes in left ventricular regional wall motion in study population
timeFrame: During Baseline Assessment
measure: Acute changes in left ventricular end-diastolic volume in study population
timeFrame: During Baseline Assessment
measure: Acute changes in left ventricular end-systolic volume in study population
timeFrame: During Baseline Assessment
measure: Chronic changes in left ventricular mechanical synchrony
timeFrame: Baseline to 12 months
measure: Chronic changes in left ventricular regional wall motion
timeFrame: Baseline to 12 months
measure: Chronic changes in left ventricular end-diastolic volume
timeFrame: Baseline to 12 months
measure: Chronic changes in left ventricular end-systolic volume
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Change in 6 Minute Hall Walk (6MHW)
timeFrame: Baseline to 12 months
measure: Change in Kansis City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Baseline to 12 months
Other outcomes:
measure: Correlation in electrical dyssynchrony and left ventricular function in study population
timeFrame: Baseline to 12 months
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute - Abbott Northwestern Hospital (MHI West)
state: Minnesota
city: Saint Paul
country: United States
facility: United Heart & Vascular Clinic - Nasseff Specialty Center (MHI East)
state: Minnesota
Study officials:
affiliation: Allina Heath System
name: Alan J Bank, MD
role: PRINCIPAL_INVESTIGATOR
References: