Acute Decompensated Heart FailurePhase 1NCT03924102
Cardiac Perfusion and Metabolism With [11C] Acetate PET/CT is Associated With Hematopoietic System Activation in Acute Decompensated Heart Failure: An Imaging Sub-study
A Phase 1 study testing Cardiac Perfusion and Metabolism with [11C] Acetate PET/CT in people with Acute Decompensated Heart Failure, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this sub-study is to use positron emission tomography and computed tomography imaging (PET/CT) with an investigational drug called [11C] acetate to see if inflammation in patients with acute decompensated heart failure (ADHF) can cause changes in blood flow and oxygen use in the heart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- Cardiac Perfusion and Metabolism with [11C] Acetate PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2025to 31 Oct 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- Enrollment in the UAB CMC-ADHF study under the separate UAB approved research protocol (IRB-300000114, PI Rajapreyar)
- Negative urine or serum β-hCG test within 48 hours of [11C] acetate administration in women of child bearing 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, 35294
About this study
The purpose of this sub-study is to use positron emission tomography and computed tomography imaging (PET/CT) with an investigational drug called [11C] acetate to see if inflammation in patients with acute decompensated heart failure (ADHF) can cause changes in blood flow and oxygen use in the heart. This study may help physicians better understand how to treat patients diagnosed with ADHF in the future.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- Cardiac Perfusion and Metabolism with [11C] Acetate PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Perfusion and Metabolism with [11C] Acetate PET/CTDrug
A rest and stress imaging study will be conducted on the PET/CT scanner with [11C] Acetate.
| Study group | Role | What they receive |
|---|---|---|
| patients with acute decompensated systolic and diastolic heart | Experimental | Not described Receives: Drug: Cardiac Perfusion and Metabolism with [11C] Acetate PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation in patients with acute decompensated heart failure (ADHF) will be measured with rest-stress [11C] acetate PET/CT to see if the inflammation can cause changes in the blood flow and oxygen use in the heart.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start31 Dec 2025 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Why it stopped: The study was not able to enroll any eligible subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924102
- Sponsor's protocol ID
- R19-056
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2019
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Perfusion and Metabolism With [11C] Acetate PET/CT is Associated With Hematopoietic System Activation in Acute Decompensated Heart Failure: An Imaging Sub-study
- ClinicalTrials.gov ID
- NCT03924102
- Acronym / sponsor ID
- R19-056
- Conditions
- Acute Decompensated Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not able to enroll any eligible subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 23 Apr 2019 (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 purpose of this sub-study is to use positron emission tomography and computed tomography imaging (PET/CT) with an investigational drug called [11C] acetate to see if inflammation in patients with acute decompensated heart failure (ADHF) can cause changes in blood flow and oxygen use in the heart. This study may help physicians better understand how to treat patients diagnosed with ADHF in the future.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with acute decompensated systolic and diastolic heart | Experimental | Drug: Cardiac Perfusion and Metabolism with [11C] Acetate PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age.
- Enrollment in the UAB CMC-ADHF study under the separate UAB approved research protocol (IRB-300000114, PI Rajapreyar)
- Negative urine or serum β-hCG test within 48 hours of [11C] acetate administration in women of child bearing 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 (4 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).
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 |
|---|---|---|
| Cardiac Perfusion and Metabolism with [11C] Acetate PET/CTA rest and stress imaging study will be conducted on the PET/CT scanner with [11C] Acetate. | Drug | patients with acute decompensated systolic and diastolic heart |
Primary outcome
Inflammation in patients with acute decompensated heart failure (ADHF) will be measured with rest-stress [11C] acetate PET/CT to see if the inflammation can cause changes in the blood flow and oxygen use in the heart.
Time frame: 3 years
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 7 Apr 2023.
Related trials for Acute Decompensated Heart Failure
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
Acute Decompensated Heart Failure (ADHF)
Recruiting
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
Recruiting
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Acute Decompensated 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiac Perfusion and Metabolism with [11C] Acetate PET/CT in people with Acute Decompensated Heart Failure, run by University of Alabama at Birmingham 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 4 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 7 Apr 2023. 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?
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?
Inflammation in patients with acute decompensated heart failure (ADHF) will be measured with rest-stress [11C] acetate PET/CT to see if the inflammation can cause changes in the blood flow and oxygen use in the heart. (time frame: 3 years). 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 7 Apr 2023.