Biomarker Study: Heart Failure Patients at Risk

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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 consisting of neuropsychological testing and blood draw. After indicated interest in the study, participants will be screened either in person during a regularly scheduled clinic visit or by phone for eligibility. After consenting, participants will be scheduled for a baseline testing session. One session, lasting about 3 hrs, will include neuropsychological testing and a blood draw. After completion of baseline testing, participants who agree to take part in the clinical trial will begin a 12-week treatment of Ang-(1-7) via daily subcutaneous injections. During the drug treatment, participants will be called weekly to ensure that everything is going well with the injections. After participants have completed the 12-week injection period, participants will be scheduled for a second appointment which will include a blood draw and neuropsychological testing. All participant will be scheduled for a 12-month follow-up, which will include a blood draw and neuropsychological testing. Participants will be called every second month by research staff for a brief update on changes to health status, and to increase compliance with the 12-month follow-up.

Our One-Year outcome for this study is to provide early proof-of-concept clinical trial data that will support a larger, more comprehensive NIH funded study on the safety and efficacy of Ang-(1-7) to prevent cognitive impairment in HF patients at risk for developing VCID/ADRD. Our Long-Term outcome is to demonstrate whether plasma NfL exhibits characteristics making it useful as a Prognostic Biomarker to predict cognitive decline in early heart disease-associated VCID and identify pre VCID-symptomatic in individuals with symptomatic HF. Our goal will be to use levels of plasma Nfl as an enrollment enrichment factor in future trials to allow enrollment or stratification of patients more likely to develop VCID or ADRD and be responsive to Ang-(1-7) therapy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Treatments: Angiotensin I (1-7)

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.