NCT07856043 · Phase 1 · NOT YET RECRUITING
[11C]PS13 PET Imaging of Neuroinflammation in Heart Failure With Reduced Ejection Fraction
This small study uses an experimental brain scan tracer, called PS13, to look at brain inflammation in people with heart failure and mild memory problems. Each person gets a scan before and about 12 weeks after starting sacubitril-valsartan, a heart drug their cardiologist already prescribed. It is a Phase 1 pilot, meaning an early check on feasibility and safety, not proof of any benefit.
You may qualify if
- 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)
You're excluded if
- 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)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-10-02