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[11C]PS13 PET Imaging of Neuroinflammation in Heart Failure With Reduced Ejection Fraction

Neuroinflammation as a Therapeutic Target in Heart Failure-Related Cognitive Decline: A Feasibility PET Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: PET scans, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In this pilot study, 18 patients with heart failure and mild memory or thinking problems who are being started on sacubitril-valsartan by their cardiologist (as standard clinical care) will undergo two brain PET scans: one before starting sacubitril-valsartan, and one approximately 12 weeks after."
  • "The study will also assess memory, thinking, daily function, mood, and social well-being using standard questionnaires."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses an experimental drug called PS13 with PET brain scans to measure brain inflammation before and about 12 weeks after starting sacubitril-valsartan. It will test whether this heart failure medicine is linked to changes in brain inflammation. It is for adults ages 50–75 whose hearts pump weakly and who have mild memory or thinking problems.

Heart failure reduces the amount of blood the heart pumps, which can lead to memory and thinking problems in many patients. One possible reason is that heart failure triggers brain inflammation, a process in which certain brain immune cells (called microglia) become overactive. A heart failure medication called sacubitril-valsartan has been shown to reduce the risk of developing dementia, but it is not known whether this is because it reduces brain inflammation. This study uses a new experimental brain scan drug called \[11C\]PS13 (PS13) to measure brain inflammation directly and non-invasively, using a technique called positron emission tomography (PET). PS13 sticks to a molecule called COX-1, which is found mainly in brain immune cells (microglia). By measuring how much PS13 accumulates in the brain, researchers can estimate how much brain inflammation is present. In this pilot study, 18 patients with heart failure and mild memory or thinking problems who are being started on sacubitril-valsartan by their cardiologist (as standard clinical care) will undergo two brain PET scans: one before starting sacubitril-valsartan, and one approximately 12 weeks after. The study will also assess memory, thinking, daily function, mood, and social well-being using standard questionnaires. The study will test whether sacubitril-valsartan is associated with measurable changes in brain inflammation, and whether this type of imaging is feasible in heart failure patients. The study is funded by the American Heart Association and the National Institute on Aging, and an independent Data and Safety Monitoring Board oversees participant safety. The results will be used to design a larger study.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 50–75 years old.
  • You have heart failure with reduced pumping strength. A heart scan in the past 12 months must show an ejection fraction of 40% or less, meaning the heart pumps out no more than 40% of its blood with each beat.
  • You score 18–25 on the MoCA, a test of memory and thinking.
  • Your heart doctor has decided to start you on sacubitril-valsartan as part of your usual care.
  • Your heart failure is stable and rated NYHA Class I–III, a scale based on symptoms during activity.
  • You can give written consent to join the study.
  • You can lie flat for up to 90 minutes for a PET scan.

Who can't join

  • You have a brain, mental health, or other illness that could affect thinking or study results, such as a major stroke, brain tumor, severe brain injury, epilepsy, multiple sclerosis, schizophrenia, or bipolar disorder. You currently misuse or are dependent on drugs or alcohol.
  • Your heart failure is unstable, has suddenly worsened within 4 weeks, or is Class IV, with symptoms at rest. You were hospitalized for heart or blood vessel problems within 4 weeks, or had heart surgery within 3 months.
  • You cannot lie flat for about 90 minutes because of fluid in your lungs or breathing trouble, cannot stay still for the scan, or weigh more than the scanner allows.
  • You have a heart device that is not approved for MRI scans and no brain MRI from the past 3 years is available. You have another implant that makes MRI unsafe, such as certain brain stimulators, hearing implants, or clips on brain blood vessels.
  • You are pregnant or breastfeeding. Your recent research radiation exposure plus this study would exceed FDA limits. You used NSAIDs, pain medicines such as ibuprofen, within 2 weeks before either PET scan; aspirin at 100 mg a day or less is allowed.
  • You have severe kidney problems, with an eGFR kidney test below 30, or another condition that could affect how the scan drug leaves your body or how test results are read. You have an active illness that causes inflammation throughout the body or makes the immune system attack healthy tissue.
  • You have blood vessel disease or another condition that prevents placing a thin tube in a wrist artery. Blood thinners that greatly raise bleeding risk may also rule you out, including warfarin with an INR blood test above 3.0 or treatment-dose heparin. The study doctor reviews direct oral blood thinners individually.
  • You donated whole blood or plasma within 8 weeks before the first PET scan, or will not avoid blood donation during the study. You cannot understand English, which is needed for the memory test and consent process.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 50-75 years * Diagnosis of HFrEF (left ventricular ejection fraction ≤40% documented by echocardiography or cardiac imaging within the prior 12 months) * Montreal Cognitive Assessment (MoCA) score 18-25 (mild cognitive impairment) * Being initiated on sacubitril-valsartan per treating cardiologist's clinical judgment in accordance with current guideline-directed medical therapy for HFrEF * Clinically stable HF (NYHA functional Class I-III) at time of enrollment * Ability to provide written informed consent * Ability to lie flat for up to 90 minutes (required for PET scan acquisition) Exclusion Criteria: * Neurologic, psychiatric, or medical condition that may cause cognitive dysfunction or affect study data interpretation (e.g., major stroke, brain tumor, severe TBI, epilepsy, multiple sclerosis, schizophrenia, bipolar disorder) * Clinically unstable HF or acute decompensated heart failure within 4 weeks prior to enrollment * NYHA functional Class IV heart failure * Recent hospitalization for cardiovascular reasons within 4 weeks of enrollment * Severe pulmonary congestion or orthopnea precluding lying flat for \~90 minutes * Recent cardiac surgery within 3 months of enrollment * Implanted cardiac device (e.g., pacemaker, ICD, CRT-D) that is non-MRI-conditional, in the absence of an available clinical brain MRI from within the past 3 years * Other implanted device contraindicated for MRI (e.g., deep brain stimulator, cochlear implant, intracranial aneurysm clip) * Current drug or alcohol abuse or dependence * Recent research radiation exposure that combined with this study would exceed allowable limits as determined by the FDA * Inability to remain still on the scanner bed or body weight exceeding scanner maximum * Use of NSAIDs other than low-dose aspirin (≤100 mg/day) within 2 weeks prior to each \[11C\]PS13 PET scan * Pregnancy or breastfeeding * Severe renal impairment (eGFR \<30 mL/min/1.73m²) or other condition that may affect radioligand clearance or biomarker interpretation * Active systemic inflammatory or autoimmune disease * Peripheral vascular disease or other condition precluding radial arterial catheter placement * Anticoagulation at therapeutic levels that would substantially increase the risk of arterial line placement (e.g., warfarin with INR \>3.0, therapeutic heparin); patients on direct oral anticoagulants (DOACs) are assessed individually by the study physician * Whole blood or plasma donation within 8 weeks (56 days) before the first PET scan, or unwillingness to refrain from blood donation for the duration of study participation * Non-English speaking (the MoCA and the consent process require English-language comprehension)

Study sites (1)

NY