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ECG for Programming in CRT (EPIC)
Patients with heart failure and left bundle branch block benefit from Cardiac Resynchronization Therapy (CRT) that delivers pacing from right ventricle (RV) and left ventricle (LV) synchronously, resulting in electrical ventricular resynchrony followed by revere structural cardiac remodeling and thereby reduced heart failure symptoms, hospitalizations and death. It is not known if programming an individually optimized RV-LV pacing offset to maximize electrical resynchrony can improve benefit from CRT.
The proposed study is a randomized controlled trial in patients undergoing implant of a CRT pacemaker/defibrillator device for clinical indications to evaluate benefit of RV-LV offset programming using electrocardiogram (ECG) vs. standard nominal CRT programming without RV-LV offset. Patients receiving CRT devices will be randomized to either (A) active intervention of programming RV-LV pacing offset to optimize ECG or to (B) active control of nominally programming CRT device without RV- LV offset. The patients will be followed to evaluate change in echocardiogram, quality of life, functional evaluation and a blood marker for heart failure.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Systolic Heart Failure Cardiac Resynchronization Therapy Electrocardiography | Device: Programming individualized RV-LV pacing offset to optimize ECG Device: Nominally programming CRT device without RV-LV offset | Not Applicable |
Once the eligibility for the study is determined and patient has consented for participation, all study participants will undergo a baseline evaluation (within 6 weeks prior to 2 weeks after CRT device implant/upgrade). Echocardiogram, quality-of-life questionnaire, 6-minute hall walk, blood test, vital signs, ECGs, device interrogation and baseline demographic and medical history including chart review will be obtained. After CRT device implant/upgrade, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs and echocardiography. A randomized assignment using a random allocation table in REDCap will be used to program patients to (A) intervention or (B) control RV-LV offset setting. Patients will return for study follow-up between 3-12 months. Follow-up evaluations will include echocardiography, quality-of-life questionnaire, 6-minute hall walk test, blood test, vital signs, ECGs, device interrogation, and follow-up medical history including chart review. The patients will continue to be in extended follow-up through review of their medical charts till the end of the study (12 months from date of CRT implant/upgrade of the the last study participant).
Treatment and control arms: All study patients will receive standard of care clinically indicated medical and device therapy per their treating physicians. After implant of a clinically indicated CRT device or upgrade of a preexisting pacemaker or defibrillator device to CRT system, participants will be randomized 1:1 to treatment arms (A) active intervention of programming individualized RV-LV pacing offset to optimize ECG or to (B) active control of nominally programming CRT device without RV-LV offset. Of note, both intervention and control treatment are active FDA-approved CRT therapies and no investigational device or programming will be used, and no clinically indicated treatment will be withheld from any patient. At any time, if in the judgment of the patient's treating physicians or the research team, any treatment including CRT programming different from the study protocol is necessitated for clinical reasons, the appropriate clinically indicated changes will be made. At the end of the study, if the participant is clinically doing well and the programmed CRT settings are deemed clinically appropriate they will be retained, else the CRT programming may be changed as per standard of care.
Enrolled participants who have a failed or unsatisfactory LV lead implant will not be randomized.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 4 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Electrocardiogram for Programming in Cardiac Resynchronization Therapy |
| Actual Study Start Date : | April 22, 2019 |
| Actual Primary Completion Date : | November 21, 2019 |
| Actual Study Completion Date : | November 21, 2019 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Individualized RV-LV Pacing Offset |
Device: Programming individualized RV-LV pacing offset to optimize ECG
After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. The RV-LV offset that optimizes the paced QRS morphology on ECG will be programmed.
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| Active Comparator: No RV-LV Pacing Offset |
Device: Nominally programming CRT device without RV-LV offset
After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. Nominal standard-of-care CRT programming with no RV-LV offset will be programmed.
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- The Primary Outcome is Echocardiographic LV End-systolic Volume. [ Time Frame: 3-12 months ]LV end-systolic volume is a reliable surrogate for clinical outcomes in clinical heart failure trials.
| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients ≥18 years of age who are able to give consent.
- Diagnosis of systolic heart failure.
- Planned to undergo new CRT device implant (or upgrade of preexisting pacemaker or defibrillator device to CRT system) for standard clinical indications.
- Expected to have over 95% heart beats resynchronized with CRT (absence of competing arrhythmias or plans to not immediately activate CRT therapy).
Exclusion Criteria:
- Unable to comply with the study follow-up.
- Life expectancy ≤1 year.
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| Principal Investigator: | Amit Noheria, MBBS, SM | Washington University School of Medicine | |
| Study Director: | Sandeep Sodhi, MD | Washington University School of Medicine |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 30, 2019 | ||||||
| First Posted Date ICMJE | May 3, 2019 | ||||||
| Results First Submitted Date ICMJE | August 5, 2020 | ||||||
| Results First Posted Date ICMJE | December 3, 2020 | ||||||
| Last Update Posted Date | December 3, 2020 | ||||||
| Actual Study Start Date ICMJE | April 22, 2019 | ||||||
| Actual Primary Completion Date | November 21, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
The Primary Outcome is Echocardiographic LV End-systolic Volume. [ Time Frame: 3-12 months ] LV end-systolic volume is a reliable surrogate for clinical outcomes in clinical heart failure trials.
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| Original Primary Outcome Measures ICMJE |
Reverse cardiac remodeling [ Time Frame: 3-12 months ] LV end-systolic volume on echocardiography
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| Change History | |||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures |
Reverse cardiac remodeling in patients with absolute optimal RV-LV offset ≥40 ms [ Time Frame: 3-12 months ] LV end-systolic volume on echocardiography
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| Descriptive Information | |||||||
| Brief Title ICMJE | ECG for Programming in CRT | ||||||
| Official Title ICMJE | Electrocardiogram for Programming in Cardiac Resynchronization Therapy | ||||||
| Brief Summary |
Patients with heart failure and left bundle branch block benefit from Cardiac Resynchronization Therapy (CRT) that delivers pacing from right ventricle (RV) and left ventricle (LV) synchronously, resulting in electrical ventricular resynchrony followed by revere structural cardiac remodeling and thereby reduced heart failure symptoms, hospitalizations and death. It is not known if programming an individually optimized RV-LV pacing offset to maximize electrical resynchrony can improve benefit from CRT. The proposed study is a randomized controlled trial in patients undergoing implant of a CRT pacemaker/defibrillator device for clinical indications to evaluate benefit of RV-LV offset programming using electrocardiogram (ECG) vs. standard nominal CRT programming without RV-LV offset. Patients receiving CRT devices will be randomized to either (A) active intervention of programming RV-LV pacing offset to optimize ECG or to (B) active control of nominally programming CRT device without RV- LV offset. The patients will be followed to evaluate change in echocardiogram, quality of life, functional evaluation and a blood marker for heart failure. |
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| Detailed Description |
Once the eligibility for the study is determined and patient has consented for participation, all study participants will undergo a baseline evaluation (within 6 weeks prior to 2 weeks after CRT device implant/upgrade). Echocardiogram, quality-of-life questionnaire, 6-minute hall walk, blood test, vital signs, ECGs, device interrogation and baseline demographic and medical history including chart review will be obtained. After CRT device implant/upgrade, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs and echocardiography. A randomized assignment using a random allocation table in REDCap will be used to program patients to (A) intervention or (B) control RV-LV offset setting. Patients will return for study follow-up between 3-12 months. Follow-up evaluations will include echocardiography, quality-of-life questionnaire, 6-minute hall walk test, blood test, vital signs, ECGs, device interrogation, and follow-up medical history including chart review. The patients will continue to be in extended follow-up through review of their medical charts till the end of the study (12 months from date of CRT implant/upgrade of the the last study participant). Treatment and control arms: All study patients will receive standard of care clinically indicated medical and device therapy per their treating physicians. After implant of a clinically indicated CRT device or upgrade of a preexisting pacemaker or defibrillator device to CRT system, participants will be randomized 1:1 to treatment arms (A) active intervention of programming individualized RV-LV pacing offset to optimize ECG or to (B) active control of nominally programming CRT device without RV-LV offset. Of note, both intervention and control treatment are active FDA-approved CRT therapies and no investigational device or programming will be used, and no clinically indicated treatment will be withheld from any patient. At any time, if in the judgment of the patient's treating physicians or the research team, any treatment including CRT programming different from the study protocol is necessitated for clinical reasons, the appropriate clinically indicated changes will be made. At the end of the study, if the participant is clinically doing well and the programmed CRT settings are deemed clinically appropriate they will be retained, else the CRT programming may be changed as per standard of care. Enrolled participants who have a failed or unsatisfactory LV lead implant will not be randomized. |
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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Terminated | ||||||
| Actual Enrollment ICMJE |
4 | ||||||
| Original Estimated Enrollment ICMJE |
250 | ||||||
| Actual Study Completion Date ICMJE | November 21, 2019 | ||||||
| Actual Primary Completion Date | November 21, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 100 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03936608 | ||||||
| Other Study ID Numbers ICMJE | 201901208 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Washington University School of Medicine | ||||||
| Study Sponsor ICMJE | Washington University School of Medicine | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Washington University School of Medicine | ||||||
| Verification Date | November 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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