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NCT07856043

PHASE1

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

Sponsor: Stony Brook University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

50 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-01

Completion Date

2028-12-31

Last Updated

2026-10-02

Healthy Volunteers

Conditions

Heart Failure With Reduced Ejection Fraction Cognitive Impairment, Mild Neuroinflammation Vascular Contributions to Cognitive Impairment and Dementia (VCID)

Interventions

DRUG

[11C]PS13: [carbon-11]PS13; COX-1 PET radioligand

\[11C\]PS13 is an investigational positron emission tomography (PET) radioligand targeting cyclooxygenase-1 (COX-1), an enzyme primarily localized in microglia involved in neuroinflammation. Synthesized on the day of each scan at the Stony Brook BAHL cGMP or FERM facility, administered as a single intravenous bolus (up to 20 mCi) per PET visit. Administered under FDA IND 177118 (21 CFR Part 312). Not FDA-approved; experimental.

DRUG

Sacubitril-Valsartan

Angiotensin receptor-neprilysin inhibitor (ARNI) initiated by the participant's treating cardiologist per ACC/AHA/HFSA guideline-directed medical therapy for HFrEF. The dose, titration, and monitoring of sacubitril-valsartan are entirely at the discretion of the treating cardiologist and are not research procedures. The timing of the follow-up PET scan (\~12 weeks post-initiation) is aligned with expected clinical stabilization on the drug.

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)

Locations (1)

Stony Brook University Medical Center

Stony Brook, New York, United States