Optimizing CRT With ECGI (optCRT)
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|ClinicalTrials.gov Identifier: NCT03492788|
Recruitment Status : Terminated (Study lost access to ECGI)
First Posted : April 10, 2018
Last Update Posted : May 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Systolic Left Bundle-Branch Block||Other: ECGI-optimized VV-offset Other: Zero VV-offset||Not Applicable|
Heart failure (HF) with reduced ejection fraction is a major global health problem. Every year, over 200,000 patients with HF and electrical abnormalities receive device implants for Cardiac Resynchronization Therapy (CRT). However, one-third of these patients receiving CRT fail to clinically improve, a large population with refractory HF symptoms, high mortality, and tremendous healthcare costs. The overall objective of the study is to improve the clinical response to CRT by physiological optimization of CRT programming with individualized ventriculo-ventricular (VV) offset, guided by novel 4-dimensional panoramic electroanatomical heart mapping using Electrocardiographic Imaging (ECGI). ECGI is a high-resolution, non-invasive, validated technique using 250 recording electrodes combined with heart-torso anatomy from chest CT.
- Assess the acute impact of ECGI-guided CRT optimization on hemodynamic heart function.
- Determine the impact of ECGI-guided CRT optimization on reverse heart remodeling at 6 months.
The study will enroll 56 adult patients undergoing CRT for standard clinical indications.
- Compare the impact of ECGI-guided CRT optimization vs. standard-of-care (zero VV offset) on acute hemodynamic function i.e. left ventricular stroke volume on Doppler echocardiography.
- Randomize patients to (a) ECGI-guided CRT optimization or (b) standard-of-care (zero VV offset). Patients will be crossed-over at 6 months and serve as their own controls. The primary outcome will be the difference in heart remodeling, i.e. % reduction of left ventricular end-systolic volume (LVESV) from baseline, between the two groups after 6 months. Reduction in LVESV is a validated physiological marker of CRT response that strongly predicts lower mortality and HF events. The secondary outcomes will include quality-of-life (Kansas City Cardiomyopathy Questionnaire), functional performance (6-minute hall walk distance) and a prognostic biomarker (serum N-terminal proBNP).
The results of this important study will provide key mechanistic insights on the salutary effects of CRT on reverse heart remodeling and enhance the understanding of failure in CRT response. Physiologically tailored CRT therapy would improve individual patient health by reducing CRT non-responders, and decrease the economic burden of refractory HF.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Optimizing Cardiac Resynchronization Therapy With Electrocardiographic Imaging|
|Actual Study Start Date :||December 28, 2017|
|Actual Primary Completion Date :||October 5, 2018|
|Actual Study Completion Date :||October 5, 2018|
|Active Comparator: ECGI-optimized VV-offset||
Other: ECGI-optimized VV-offset
ECGI guided optimization of VV offset programming of CRT device
|Placebo Comparator: Zero VV-offset||
Other: Zero VV-offset
Standard-of-care nominal (zero VV-offset) programming of CRT device
- LV reverse remodeling [ Time Frame: 6 months ]Echocardiographically evaluated % reduction in LV end-systolic volume (LVESV) from baseline is the primary outcome measure. A reduction in the LVESV is a validated surrogate marker of improved HF outcomes including reduced hospitalizations and increased survival.
- Quality-of-life [ Time Frame: 6 months ]The validated standardized abbreviated Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) is a secondary outcome measure. The KCCQ-12 is a self-reported disease-specific health status measure for patients with HF. The overall summary KCCQ-12 score ranges from 0 (poor) to 100 (excellent) and represents the summation of the patient's physical limitation, symptom frequency, quality of life and social limitation. Improvement in the KCCQ-12 overall summary score as compared to the baseline will be assessed.
- Functional performance [ Time Frame: 6 months ]A standard six-minute hall walk distance (meters) will be measured at baseline and at followup to assess increase in walking distance as a reproducible measure of functional performance.
- Prognostic biomarker [ Time Frame: 6 months ]Serum N-terminal proBNP is a validated prognostic biomarker that is elevated with worsening HF and is associated with worse outcomes including mortality. The NT-proBNP level at followup will be compared to baseline as a marker of improvement in heart failure.
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): NCT03492788
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Amit Noheria, MBBS, SM||Assistant Professor of Medicine|