Heart Failure, SystolicNCT03398369
Mechanistic Clinical Trial of Advanced Imaging for CRT
A study testing CMR/CTA Guidance for CRT in people with Heart Failure, Systolic, run by University of Virginia at 1 site in United States.
Trial summary
This is a mechanistic clinical trial with randomization to guidance for the CRT procedure using cardiac magnetic resonance (CMR) and computed tomography angiography (CTA) versus a standard procedure. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- CMR/CTA Guidance for CRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2018to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic systolic HF
- LVEF 35% or less
- Guideline-based class I or II indication for CRT
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 CMR (does not include pacemakers and ICDs)
Show all 12Show fewer
- Severe claustrophobia
- Acute kidney injury
- Acute renal failure or chronic kidney disease with GFR < 45 cc/min/1.73m2
- Liver transplant
- Gadolinium allergy
- >10% premature ventricular contraction (PVC) burden; and 13) estimated >10% atrial fibrillation (AF) burden based on available clinical data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22908
John Hoover, 434-243-4861, jrh5r@hscmail.mcc.virginia.edu
About this study
Official title: Advanced Imaging and Inflammatory Markers to Define Mechanisms of Response to CRT
This is a mechanistic clinical trial with randomization to guidance for the CRT procedure using cardiac magnetic resonance (CMR) and computed tomography angiography (CTA) versus a standard procedure.
Read the detailed description
At baseline, patients will have CMR, CTA, echocardiography, blood testing, and cardiopulmonary exercise testing. They will also complete a heart failure questionnaire. In patients randomized to CMR guidance for the CRT procedure, LV lead placement will be guided by the MRI information related to scar, activation and anatomy. Patients will have follow-up assessments at 6 and 12 months. There will also be clinical follow-up for survival free of appropriate ICD therapies over 3 years.
- Conditions
- Heart Failure, Systolic
- Being tested
- CMR/CTA Guidance for CRT
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMR/CTA Guidance for CRTDiagnostic test
The intervention is the use of CMR and CTA to determine the optimal pacing site in the left ventricle for cardiac resynchronization therapy (CRT) and guide left ventricular lead placement.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | CMR-Guided CRT Receives: Diagnostic Test: CMR/CTA Guidance for CRT |
| Control | No intervention | Standard CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular end-systolic volume (LVESV) improvement
Change in LVESV with cardiac resynchronization therapy (CRT)
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start5 Jan 2018
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Jan 2025 (estimated)
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 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 Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398369
- Sponsor's protocol ID
- UVAMRICRTTRIAL
- Status last verified
- Feb 2020
- First submitted
- 7 Jan 2018
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Imaging and Inflammatory Markers to Define Mechanisms of Response to CRT
- ClinicalTrials.gov ID
- NCT03398369
- Acronym / sponsor ID
- UVAMRICRTTRIAL
- Conditions
- Heart Failure, Systolic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 12 Jan 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 is a mechanistic clinical trial with randomization to guidance for the CRT procedure using cardiac magnetic resonance (CMR) and computed tomography angiography (CTA) versus a standard procedure.
Detailed description
At baseline, patients will have CMR, CTA, echocardiography, blood testing, and cardiopulmonary exercise testing. They will also complete a heart failure questionnaire. In patients randomized to CMR guidance for the CRT procedure, LV lead placement will be guided by the MRI information related to scar, activation and anatomy. Patients will have follow-up assessments at 6 and 12 months. There will also be clinical follow-up for survival free of appropriate ICD therapies over 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: CMR/CTA Guidance for CRTCMR-Guided CRT |
| Control | No intervention | –Standard CRT |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic systolic HF
- LVEF 35% or less
- Guideline-based class I or II indication for CRT
Key exclusion criteria (12 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 |
|---|---|---|
| CMR/CTA Guidance for CRTThe intervention is the use of CMR and CTA to determine the optimal pacing site in the left ventricle for cardiac resynchronization therapy (CRT) and guide left ventricular lead placement. | Diagnostic test | Intervention |
Primary outcome
Left ventricular end-systolic volume (LVESV) improvement
Time frame: One Year
Change in LVESV with cardiac resynchronization therapy (CRT)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Heart Failure, Systolic
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
RecruitingPhase 1
A Study of LY3971297 in Participants With Heart Failure
Heart Failure, Heart Failure, Diastolic
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
RecruitingPhase 1/2
Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
Heart Failure, Ischemic Heart Failure
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.
Kenneth C Bilchick, MD principal investigator
University of Virginia Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMR/CTA Guidance for CRT in people with Heart Failure, Systolic, 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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 6 Feb 2020. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kenneth C Bilchick, MD (4349242465, bilchick@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular end-systolic volume (LVESV) improvement (time frame: One Year). 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 6 Feb 2020.