Status:
UNKNOWN
Biomarker Study: Heart Failure Patients at Risk
Lead Sponsor:
University of Arizona
Conditions:
Heart Failure NYHA Class II
Heart Failure NYHA Class III
Eligibility:
All Genders
45+ years
Phase:
PHASE1
PHASE2
Brief Summary
In order to determine if NfL can be a prognostic biomarker for VCID, participants will undergo a baseline evaluation consisting of neuropsychological testing and a blood draw with a 12-month follow-up...
Detailed Description
The investigators are proposing that neurofilament light (NfL) polypeptide might serve as a prognostic biomarker in blood that can help predict clinical progression in early VCID and identify pre-VCID...
Eligibility Criteria
Inclusion
- Participants may be included in the study if they are:
- 45 years old and older
- Diagnosed at least 90 days prior to enrollment with stable NYHA Class II-IV HF, with symptoms during mild or moderate exercise but not at rest (i.e., shortness of breath),
- On a stable medical regimen and free from hospitalizations in the prior 30 days,
- Fluent English speakers.
Exclusion
- Participants will be excluded from the study if there is evidence of:
- Decompensated heart failure
- Symptoms or signs of active coronary ischemia
- Systolic blood pressure \<95 mmHg
- Significant lung disease (FEV1\< 1.5 L, pO2 \<70 on room air, pCO2 \>45)
- Active substance abuse or a history of substance abuse with cocaine, ecstasy, LSD, or IV drugs
- History of or current seizure disorder or on medications for seizures (with the exception of childhood febrile seizures)
- Neurological, psychiatric, or medical illness or injury expected to interfere with cognitive function including but not limited to stroke, head injury, Alzheimer's, Parkinson's, or brain cancer
- Current depression (Patient Health Questionnaire-9 score \>10)
- Any condition which may prevent the subject from adhering to the study protocol such as significantly impaired vision.\\
- Note: Participants that have contraindications for MRI may be enrolled, but will not take part in the MRI portion of the study.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05336175
Start Date
April 1 2022
End Date
December 1 2023
Last Update
April 20 2022
Active Locations (2)
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1
Banner - University Medical Center
Phoenix, Arizona, United States, 85006
2
University of Arizona
Tucson, Arizona, United States, 85721