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NEURO-HF

Not yet recruitingPhase 1

[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

Lead sponsor

Stony Brook University

Asset

Sacubitril-Valsartan

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Vascular cognitive impairment / dementia

Key I/E criterion

•MoCA 18-25

Primary endpoint

•[11C]PS13 Total Distribution Volume (VT) in Global Gray Matter

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Other grant26RIRA1639136American Heart Association

Org study IDIRB2026-00185

NCT IDNCT07856043

NihR21AG102953

Timeline

Milestones

Study start2026-10-01estimated

Study first posted2026-10-02actual

Last update posted2026-10-02actual

Primary completion2028-06-30estimated

Study completion2028-12-31estimated

Assets

Drug assets

Sacubitril-Valsartan

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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)

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Global cognition

Function / daily living

Neuroimaging

Other clinical outcomes

Global cognition

1 endpoint

Secondary/protocol endpoint

Change in Neurocognitive Performance (Composite Battery)

Time frame:Baseline (Visit 1) and ~12 weeks (Visit 4)

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change in Instrumental Activities of Daily Living (IADL / Lawton-Brody Scale)

Time frame:Baseline (Visit 2) and ~12 weeks (Visit 4)

change from baseline, improvement

Neuroimaging

1 endpoint

Secondary/protocol endpoint

Change in Regional [11C]PS13 VT in Specific Brain Regions of Interest

Time frame:Baseline (Visit 2) and ~12 weeks (Visit 4)

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Change in [11C]PS13 Total Distribution Volume (VT) in Global Gray Matter

Time frame:Baseline (Visit 2, prior to sacubitril-valsartan initiation) and approximately 12 weeks after initiation (Visit 4)

change from baseline, event

Secondary/protocol endpoint

Arterial Blood Input Function Quality and Radiometabolite Profile

Time frame:Baseline (Visit 2) and ~12 weeks (Visit 4)

descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Feasibility: [11C]PS13 PET Scan Completion Rate

Time frame:Through study completion, approximately 16 weeks per participant

threshold achievement, improvement

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.