Chronic Systolic Heart FailurePhase 1NCT03504891
Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades
A Phase 1 study testing MRI prior to CRT Upgrade and MRI prior to de novo CRT in people with Chronic Systolic Heart Failure and Paroxysmal VT, run by University of Virginia at 1 site in United States.
Trial summary
This study will investigate the use of cardiac MRI in patients with standard ICDs and pacemakers to inform how cardiac resynchronization therapy (CRT) can best be implemented in these patient and which patients are the best candidates for CRT. Read more about this study
- Who is it for?
- Ages 25 to 89 years
- Conditions the study is for
- Chronic Systolic Heart Failure, Paroxysmal VT
- What is being tested?
- MRI prior to CRT Upgrade and MRI prior to de novo CRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 1 Jan 2020
- Phase
- Phase 1
- 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 25 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing upgrade from an existing pacemaker or ICD to a CRT device.
Who cannot join
- inability to provide informed consent
- pregnancy
- presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
- cerebral aneurysm clips
- cochlear implants
- other metallic implants known to be contraindications to MRI (pacemakers and ICDs are allowed)
Show all 11Show fewer
- severe claustrophobia
- acute kidney injury
- acute renal failure
- gadolinium allergy
- abandoned leads
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22901
Kenneth C Bilchick, MD, 434-924-2465, bilchick@virginia.edu
About this study
This study will investigate the use of cardiac MRI in patients with standard ICDs and pacemakers to inform how cardiac resynchronization therapy (CRT) can best be implemented in these patient and which patients are the best candidates for CRT.
Read the detailed description
The scientific premise of this proposal is that left and right ventricular (LV and RV) structural characteristics in patients with existing cardiac implantable electronic devices and heart failure who may benefit from an upgrade to a cardiac resynchronization therapy (CRT) device can be assessed very effectively using cardiac MRI using sequences designed for post-device imaging. Furthermore, a comparative analysis of the differences in LV/RV structural characteristics in patients with existing devices referred for CRT upgrades versus those with de novo CRT implants is expected to be very useful for developing effective strategies for optimal patient selection for CRT upgrades and implementation of CRT upgrades in appropriate patients. Patient selection for CRT upgrades is very important considering that complication rates are higher than in de novo CRT procedures and nonresponse rates are still high. With this in mind, we are performing a study of 100 patients, including 50 prospectively enrolled patients with LVEF less than or equal to 0.35 and New York Heart Association class II-III heart failure, who will be compared with an existing cohort of 50 patients with recent de novo CRT implants, pre-CRT MRIs, and response data. The 50 prospectively enrolled patients having CRT upgrades will undergo a pre-CRT cardiac MRI, pre-CRT/post-CRT echocardiography, and pre-CRT/post-CRT cardiopulmonary exercise testing. In the first aim, we will assess differences in cardiac MRI findings between CRT upgrade patients and de novo CRT patients. In the second aim, we will assess the impact of cardiac MRI findings on LV reverse remodeling and cardiopulmonary capacity in the two groups. In summary, we propose a comprehensive prospective CRT/MRI study in CRT upgrade patients with comparison to a complete MRI dataset of patients with de novo CRT implants in order to identify key differences in MRI findings in these cohorts and the impact of these MRI-based scar and activation findings on clinical outcomes. We expect that our results will have a significant public health impact for patients with heart failure referred for CRT upgrades.
- Conditions
- Chronic Systolic Heart Failure, Paroxysmal VT
- Being tested
- MRI prior to CRT Upgrade, MRI prior to de novo CRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI prior to CRT UpgradeDiagnostic test
We will perform MRI prior to CRT to inform the optimal CRT implantation strategy in patients with existing devices undergoing upgrades versus those with de novo CRT implants. We will compare outcomes in the two groups.
MRI prior to de novo CRTDiagnostic test
We will perform MRI prior to de novo CRT implants as the comparison group.
| Study group | Role | What they receive |
|---|---|---|
| MRI Prior to CRT for Upgrades | Experimental | MRI will be performed prior to CRT upgrade. Receives: Diagnostic Test: MRI prior to CRT Upgrade |
| MRI Prior to de novo CRT Implants | Active comparator | MRI will be performed prior to de novo CRT implants. Receives: Diagnostic Test: MRI prior to de novo CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRT Response
CRT Response Based on Change in LVESV After CRT
Measured: 6 months
Secondary outcomes (2)
Improvement in Peak Oxygen Consumption
Peak VO2
Measured: 6 months
Improvement in Short Form (36) Health Survey
Assesses disability associated with heart failure. We will use the total score, which has a range of 0-100. Lower scores indicate greater disability.
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 posted20 Apr 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Systolic Heart FailureStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will have cardiac MRI prior to CRT.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Bilchick, MD, University of Virginia
- Investigators
- Kenneth C Bilchick, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504891
- Sponsor's protocol ID
- MRI FOR CRT UPGRADES
- Status last verified
- Apr 2018
- First submitted
- 12 Apr 2018
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: This research will generate MRI, echocardiographic, and cardiopulmonary exercise data in patients referred for CRT upgrades. Examples of specific data fields include the extent/distribution of myocardial scar based on late gadolinium enhancement, characterization of mechanical activation based on MRI strain imaging, baseline MRI volumetric and functional measures, changes in echocardiographic volumes and function resulting from CRT, and changes in cardiopulmonary capacity resulting from CRT.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades
- ClinicalTrials.gov ID
- NCT03504891
- Acronym / sponsor ID
- MRI FOR CRT UPGRADES
- Conditions
- Chronic Systolic Heart Failure, Paroxysmal VT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 20 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.
This study will investigate the use of cardiac MRI in patients with standard ICDs and pacemakers to inform how cardiac resynchronization therapy (CRT) can best be implemented in these patient and which patients are the best candidates for CRT.
Detailed description
The scientific premise of this proposal is that left and right ventricular (LV and RV) structural characteristics in patients with existing cardiac implantable electronic devices and heart failure who may benefit from an upgrade to a cardiac resynchronization therapy (CRT) device can be assessed very effectively using cardiac MRI using sequences designed for post-device imaging. Furthermore, a comparative analysis of the differences in LV/RV structural characteristics in patients with existing devices referred for CRT upgrades versus those with de novo CRT implants is expected to be very useful for developing effective strategies for optimal patient selection for CRT upgrades and implementation of CRT upgrades in appropriate patients. Patient selection for CRT upgrades is very important considering that complication rates are higher than in de novo CRT procedures and nonresponse rates are still high. With this in mind, we are performing a study of 100 patients, including 50 prospectively enrolled patients with LVEF less than or equal to 0.35 and New York Heart Association class II-III heart failure, who will be compared with an existing cohort of 50 patients with recent de novo CRT implants, pre-CRT MRIs, and response data. The 50 prospectively enrolled patients having CRT upgrades will undergo a pre-CRT cardiac MRI, pre-CRT/post-CRT echocardiography, and pre-CRT/post-CRT cardiopulmonary exercise testing. In the first aim, we will assess differences in cardiac MRI findings between CRT upgrade patients and de novo CRT patients. In the second aim, we will assess the impact of cardiac MRI findings on LV reverse remodeling and cardiopulmonary capacity in the two groups. In summary, we propose a comprehensive prospective CRT/MRI study in CRT upgrade patients with comparison to a complete MRI dataset of patients with de novo CRT implants in order to identify key differences in MRI findings in these cohorts and the impact of these MRI-based scar and activation findings on clinical outcomes. We expect that our results will have a significant public health impact for patients with heart failure referred for CRT upgrades.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will have cardiac MRI prior to CRT.
| Arm | Type | Receives |
|---|---|---|
| MRI Prior to CRT for Upgrades | Experimental | Diagnostic Test: MRI prior to CRT UpgradeMRI will be performed prior to CRT upgrade. |
| MRI Prior to de novo CRT Implants | Active comparator | Diagnostic Test: MRI prior to de novo CRTMRI will be performed prior to de novo CRT implants. |
Who may qualify
- Ages
- 25 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing upgrade from an existing pacemaker or ICD to a CRT device.
Key exclusion criteria (11 listed)
- inability to provide informed consent
- pregnancy
- presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
- cerebral aneurysm clips
- cochlear implants
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 |
|---|---|---|
| MRI prior to CRT UpgradeWe will perform MRI prior to CRT to inform the optimal CRT implantation strategy in patients with existing devices undergoing upgrades versus those with de novo CRT implants. We will compare outcomes in the two groups. | Diagnostic test | MRI Prior to CRT for Upgrades |
| MRI prior to de novo CRTWe will perform MRI prior to de novo CRT implants as the comparison group. | Diagnostic test | MRI Prior to de novo CRT Implants |
Primary outcome
CRT Response
Time frame: 6 months
CRT Response Based on Change in LVESV After CRT
2 secondary outcomes
Improvement in Peak Oxygen Consumption
Time frame: 6 months
Improvement in Short Form (36) Health Survey
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Individual participant dataSharing planned: Yes. This research will generate MRI, echocardiographic, and cardiopulmonary exercise data in patients referred for CRT upgrades. Examples of specific data fields include the extent/distribution of myocardial scar based on late gadolinium enhancement, characterization of mechanical activation based on MRI strain imaging, baseline MRI volumetric and functional measures, changes in echocardiographic volumes and function resulting from CRT, and changes in cardiopulmonary capacity resulting from CRT.
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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.
Kenneth C Bilchick, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRI prior to CRT Upgrade and MRI prior to de novo CRT in people with Chronic Systolic Heart Failure and Paroxysmal VT, run by University of Virginia 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 11 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: status not confirmed, as of the sponsor's last update on 3 May 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenneth C Bilchick, MD (434-924-2465, bilchick@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRT Response (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 3 May 2018.