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

Korábbi kezelés

• Clinically unstable HF or acute decompensated heart failure within 4 weeks prior to enrollment
• 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
• Use of NSAIDs other than low-dose aspirin (≤100 mg/day) within 2 weeks prior to each [11C]PS13 PET scan

Más betegség

• 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)
• NYHA functional Class IV heart failure
• 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
• Active systemic inflammatory or autoimmune disease
• Peripheral vascular disease or other condition precluding radial arterial catheter placement

Laborértékek

• Severe renal impairment (eGFR <30 mL/min/1.73m²) or other condition that may affect radioligand clearance or biomarker interpretation
• 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

Egyéb

• Recent hospitalization for cardiovascular reasons within 4 weeks of enrollment
• Severe pulmonary congestion or orthopnea precluding lying flat for ~90 minutes
• Inability to remain still on the scanner bed or body weight exceeding scanner maximum
• Pregnancy or breastfeeding
• 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)

• 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)