Mitral Valve RegurgitationEarly Phase 1NCT04795856
Understanding the Metabolic and Functional Derangement of Primary Mitral Regurgitation: a Feasibility Study Using Carbon 11(C-11) Acetate Cardiac Positron Emission Tomography Magnetic Resonance Imaging (PET-MRI)
A Early Phase 1 study testing [11C] acetate in people with Mitral Valve Regurgitation, run by University of Alabama at Birmingham.
Trial summary
The aim of this pilot imaging study is to investigate the underlying changes in myocardial oxidative metabolism, myocardial inflammation and alterations in extracellular volume in patients with chronic compensated moderate-severe primary mitral regurgitation (PMR). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mitral Valve Regurgitation
- What is being tested?
- [11C] acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2027to Aug 2028
- Phase
- Early 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- Patients with chronic, asymptomatic, compensated PMR evaluated in the UAB Structural Valve Clinic OR Normal controls identified from a normal aged matched population.
- Negative urine or serum β-human chorionic gonadotropin (hcg) test within 48 hours of [11C] acetate administration in women of childbearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.
Who cannot join
- Inability to provide informed consent
- Pregnancy
- Inability to lie still for the imaging study
- Weight exceeding the weight limit of the PET imaging table (500 pounds)
- Comorbidities including any of the following: history of coronary artery disease, prior coronary revascularization, prior myocardial infarction, prior open sternotomy, history of congestive heart failure, history of non-ischemic cardiomyopathy including dilated, restrictive, hypertrophic, amyloid heart disease, cardiac sarcoidosis, history of hypertension, diabetes mellitus, chronic kidney disease with a glomerular filtration rate (GFR) less than 60 ml/min/1.73 m2 , history of other valvular heart disease defined as mitral stenosis, aortic stenosis, more than mild aortic regurgitation, more than mild tricuspid regurgitation, history of more than mild pulmonary hypertension and history of cancer with exposure to chemotherapy or radiotherapy.
- Contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)
- Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
About this study
Official title: Understanding the Metabolic and Functional Derangement of Primary Mitral Regurgitation: a Feasibility Study Using C-11 Acetate Cardiac PET-MRI
The aim of this pilot imaging study is to investigate the underlying changes in myocardial oxidative metabolism, myocardial inflammation and alterations in extracellular volume in patients with chronic compensated moderate-severe primary mitral regurgitation (PMR). The PET tracer [11C] acetate will be used to image and quantify myocardial oxygen consumption (MVO2) in hearts of the study participants. Cardiac magnetic resonance imaging (CMR) using a gadolinium-based contrast agent (GBCA) will be performed to assess for and quantify expansion of myocardial extracellular volume (ECV) and myocardial inflammation. We will enroll a total of 12 participants, nine of whom will be patients with chronic, compensated asymptomatic moderate-severe PMR evaluated at the UAB Cardiovascular Disease and Structural Valve Clinic and three normal control subjects.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- [11C] acetate
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C] acetateDrug
PET Tracer
| Study group | Role | What they receive |
|---|---|---|
| chronic compensated moderate-severe primary mitral regurgitation (PMR) | Active comparator | Not described Receives: Drug: [11C] acetate |
| Healthy Volunteers | Active comparator | Not described Receives: Drug: [11C] acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitatively correlate metabolic findings from the PET component with quantitative T1 and T2 parametric mapping from the cardiac MR component of the hybrid PET-MR study.
Parametric analysis of T1 and T2 mapping will be performed using dedicated software (Qmap, Medis).
Measured: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study startJun 2027 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Why it stopped: lack of recruitment and PI departure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve RegurgitationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The healthy group will establish a baseline for the moderate- severe mitral valve regurgitation (PMR) group.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pradeep Bhambhvani, MD, University of Alabama at Birmingham
- Investigators
- Pradeep Bhambhvani, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795856
- Sponsor's protocol ID
- R20-178
- Status last verified
- Jan 2025
- First submitted
- 9 Mar 2021
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Metabolic and Functional Derangement of Primary Mitral Regurgitation: a Feasibility Study Using C-11 Acetate Cardiac PET-MRI
- ClinicalTrials.gov ID
- NCT04795856
- Acronym / sponsor ID
- R20-178
- Conditions
- Mitral Valve Regurgitation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of recruitment and PI departure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jun 2027 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 12 Mar 2021 (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.
The aim of this pilot imaging study is to investigate the underlying changes in myocardial oxidative metabolism, myocardial inflammation and alterations in extracellular volume in patients with chronic compensated moderate-severe primary mitral regurgitation (PMR). The PET tracer [11C] acetate will be used to image and quantify myocardial oxygen consumption (MVO2) in hearts of the study participants. Cardiac magnetic resonance imaging (CMR) using a gadolinium-based contrast agent (GBCA) will be performed to assess for and quantify expansion of myocardial extracellular volume (ECV) and myocardial inflammation. We will enroll a total of 12 participants, nine of whom will be patients with chronic, compensated asymptomatic moderate-severe PMR evaluated at the UAB Cardiovascular Disease and Structural Valve Clinic and three normal control subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The healthy group will establish a baseline for the moderate- severe mitral valve regurgitation (PMR) group.
| Arm | Type | Receives |
|---|---|---|
| chronic compensated moderate-severe primary mitral regurgitation (PMR) | Active comparator | Drug: [11C] acetate |
| Healthy Volunteers | Active comparator | Drug: [11C] acetate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age.
- Patients with chronic, asymptomatic, compensated PMR evaluated in the UAB Structural Valve Clinic OR Normal controls identified from a normal aged matched population.
- Negative urine or serum β-human chorionic gonadotropin (hcg) test within 48 hours of [11C] acetate administration in women of childbearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.
Key exclusion criteria (7 listed)
- Inability to provide informed consent
- Pregnancy
- Inability to lie still for the imaging study
- Weight exceeding the weight limit of the PET imaging table (500 pounds)
- Comorbidities including any of the following: history of coronary artery disease, prior coronary revascularization, prior myocardial infarction, prior open sternotomy, history of congestive heart failure, history of non-ischemic cardiomyopathy including dilated, restrictive, hypertrophic, amyloid heart disease, cardiac sarcoidosis, history of hypertension, diabetes mellitus, chronic kidney disease with a glomerular filtration rate (GFR) less than 60 ml/min/1.73 m2 , history of other valvular heart disease defined as mitral stenosis, aortic stenosis, more than mild aortic regurgitation, more than mild tricuspid regurgitation, history of more than mild pulmonary hypertension and history of cancer with exposure to chemotherapy or radiotherapy.
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 |
|---|---|---|
| [11C] acetatePET Tracer | Drug | Healthy Volunteers, chronic compensated moderate-severe primary mitral regurgitation (PMR) |
Primary outcome
Quantitatively correlate metabolic findings from the PET component with quantitative T1 and T2 parametric mapping from the cardiac MR component of the hybrid PET-MR study.
Time frame: 0-48 hours
Parametric analysis of T1 and T2 mapping will be performed using dedicated software (Qmap, Medis).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Pradeep Bhambhvani, MD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [11C] acetate in people with Mitral Valve Regurgitation, run by University of Alabama at Birmingham.
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 7 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: withdrawn, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Quantitatively correlate metabolic findings from the PET component with quantitative T1 and T2 parametric mapping from the cardiac MR component of the hybrid PET-MR study. (time frame: 0-48 hours). 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 24 Jan 2025.