Heart Failure, SystolicoptCRTNCT03492788
Optimizing CRT With ECGI
A study testing ECGI-optimized VV-offset and Zero VV-offset in people with Heart Failure, Systolic and Left Bundle-Branch Block, run by Washington University School of Medicine at 1 site in United States.
Trial summary
CRT is delivered from two electrodes on opposite sides of the heart [right (RV) and left ventricle (LV)] delivering stimulation for more efficient heart beats. There is flexibility in the sequence and temporal staggering of the stimulation from these two electrodes with a different optimum for different patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure, Systolic, Left Bundle-Branch Block
- What is being tested?
- ECGI-optimized VV-offset and Zero VV-offset
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2017to 5 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years of age who are able to give consent, having systolic heart failure despite treatment with guideline directed medical therapy, undergoing successful CRT device implant for standard clinical indications, expected to have over 95% heart beats resynchronized by the pacing device (absence of competing arrhythmias), and have RV or LV pacing latency (stimulus to rapid QRS deflection) ≥30 msec
Who cannot join
- Patients unable to comply with the study follow-up, life expectancy ≤1 year, suboptimal LV lead location (septal or apical)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Optimizing Cardiac Resynchronization Therapy With Electrocardiographic Imaging
CRT is delivered from two electrodes on opposite sides of the heart [right (RV) and left ventricle (LV)] delivering stimulation for more efficient heart beats. There is flexibility in the sequence and temporal staggering of the stimulation from these two electrodes with a different optimum for different patients. However, standard techniques to figure out the optimal stimulation strategy like standard 12-lead surface electrical recording (ECG) or routine ultrasound have failed. The investigators have developed ECG imaging (ECGI) with 250 electrode surface recording combined with CT scan to reconstruct high resolution 4-dimensional panoramic electrical maps of the heart. The study seeks to enroll 56 patients undergoing CRT in a clinical trail to evaluate short and long term impact of using ECGI for optimal programming of CRT.
Read the detailed description
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.
Specific Aims:
- 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.
Methods:
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.
- Conditions
- Heart Failure, Systolic, Left Bundle-Branch Block
- Being tested
- ECGI-optimized VV-offset, Zero VV-offset
- Keywords
- cardiac resynchronization therapy, electrocardiographic imaging
- Medical subject headings
- Heart Failure, Systolic, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGI-optimized VV-offsetOther
ECGI guided optimization of VV offset programming of CRT device
Zero VV-offsetOther
Standard-of-care nominal (zero VV-offset) programming of CRT device
| Study group | Role | What they receive |
|---|---|---|
| ECGI-optimized VV-offset | Active comparator | Not described Receives: Other: ECGI-optimized VV-offset |
| Zero VV-offset | Placebo comparator | Not described Receives: Other: Zero VV-offset |
What is being measured
The primary outcome is the main question the study is designed to answer.
LV reverse remodeling
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.
Measured: 6 months
Secondary outcomes (3)
Quality-of-life
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.
Measured: 6 months
Functional performance
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.
Measured: 6 months
Prognostic biomarker
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start28 Dec 2017
- Primary completion5 Oct 2018
- Study completion5 Oct 2018
Why it stopped: Study lost access to ECGI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Cardiology
- Responsible party
- Sponsor
- Investigators
- Amit Noheria, MBBS, SM, Principal investigator, Assistant Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492788
- Sponsor's protocol ID
- 201712146
- Acronym
- optCRT
- Status last verified
- Apr 2019
- First submitted
- 17 Jan 2018
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Cardiac Resynchronization Therapy With Electrocardiographic Imaging
- ClinicalTrials.gov ID
- NCT03492788
- Acronym / sponsor ID
- optCRT / 201712146
- Conditions
- Heart Failure, Systolic, Left Bundle-Branch Block
- Keywords
- cardiac resynchronization therapy, electrocardiographic imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study lost access to ECGI
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- American College of Cardiology
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- 5 Oct 2018 (actual)
- Study completion
- 5 Oct 2018 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CRT is delivered from two electrodes on opposite sides of the heart [right (RV) and left ventricle (LV)] delivering stimulation for more efficient heart beats. There is flexibility in the sequence and temporal staggering of the stimulation from these two electrodes with a different optimum for different patients. However, standard techniques to figure out the optimal stimulation strategy like standard 12-lead surface electrical recording (ECG) or routine ultrasound have failed. The investigators have developed ECG imaging (ECGI) with 250 electrode surface recording combined with CT scan to reconstruct high resolution 4-dimensional panoramic electrical maps of the heart. The study seeks to enroll 56 patients undergoing CRT in a clinical trail to evaluate short and long term impact of using ECGI for optimal programming of CRT.
Detailed description
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.
Specific Aims:
- 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.
Methods:
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECGI-optimized VV-offset | Active comparator | Other: ECGI-optimized VV-offset |
| Zero VV-offset | Placebo comparator | Other: Zero VV-offset |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ≥18 years of age who are able to give consent, having systolic heart failure despite treatment with guideline directed medical therapy, undergoing successful CRT device implant for standard clinical indications, expected to have over 95% heart beats resynchronized by the pacing device (absence of competing arrhythmias), and have RV or LV pacing latency (stimulus to rapid QRS deflection) ≥30 msec
Key exclusion criteria (1 listed)
- Patients unable to comply with the study follow-up, life expectancy ≤1 year, suboptimal LV lead location (septal or apical)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECGI-optimized VV-offsetECGI guided optimization of VV offset programming of CRT device | Other | ECGI-optimized VV-offset |
| Zero VV-offsetStandard-of-care nominal (zero VV-offset) programming of CRT device | Other | Zero VV-offset |
Primary outcome
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.
3 secondary outcomes
Quality-of-life
Time frame: 6 months
Functional performance
Time frame: 6 months
Prognostic biomarker
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Study lost access to ECGI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Noheria, MBBS, SM principal investigator
Assistant Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECGI-optimized VV-offset and Zero VV-offset in people with Heart Failure, Systolic and Left Bundle-Branch Block, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study lost access to ECGI). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LV reverse remodeling (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.