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Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults (PREVENTABLE)

PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Craig Rubin
16278
All
75 Years and over
Phase 4
This study is also accepting healthy volunteers
NCT04262206
STU-2020-0579
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Inclusion Criteria:

• Community-dwelling adults
• Age 75 years or older
Exclusion Criteria:

• Clinically evident CVD, defined as prior MI, prior stroke, prior revascularization procedure, or a secondary prevention indication for a statin as determined by their clinician.
• Hospitalization for a primary diagnosis of heart failure in the prior 12 months (Note: History of heart failure without clinically evident cardiovascular disease is not an exclusion)
• Dementia (clinically evident and/or previously diagnosed)
• Dependence in any Katz Basic Activities of Daily Living [ADL] (with the exception of urinary or bowel continence)
• Severe hearing impairment (preventing phone follow up)
• Severe visual impairment (preventing cognitive testing)
• Statin use in the past year or for longer than 5 years previously (participant reported)
• Ineligible to take atorvastatin 40 mg (clinician determined)
• Documented intolerance to statins
• Active liver disease
Drug: Atorvastatin 40 Mg Oral Tablet, Drug: Placebo oral tablet
Dementia, Cardiovascular Diseases, Unknown Sites, Cognitive Impairment, Mild
statin, older adults
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Acute Kidney Injury Genomics and Biomarkers in TAVR Study

In the last decade, transcatheter aortic valve replacement (TAVR) has become an increasingly utilized alternative procedure for replacing a stenotic aortic valve. This study collects clinical information, DNA, blood and urine samples (throughout procedural hospitalization) in order to investigate the incidence of acute kidney injury (AKI) in patients undergoing TAVR and to identify key clinical and procedural predictors of AKI. This study seeks to identify blood and urine biomarkers that can be used for early detection of AKI around the time of the procedure. The study seeks to assess for novel genetic variants associated with development of AKI after TAVR. Finally the study seeks to assess for novel genetic variants and biomarkers that are associated with adverse cardiovascular events after TAVR and to further explore how these events may inter-relate with acute kidney injury.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Amanda Fox
149974
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT02791880
STU 112015-015
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Inclusion criteria: Subjects are eligible to participate if they are undergoing TAVR for aortic stenosis at the University of Texas Southwestern Medical Center.
Exclusion Criteria:
1. The patient cannot or will not provide informed consent. 2. The patient is aged less than 18 years. 3. The patient's pre-procedural hematocrit is less than 25%. 4. The patient has known hepatitis C and/or human immunodeficiency virus infection 5. In the opinion of the principal investigator, the patient will be unlikely to complete long-term follow up for medical or social reasons.
Procedure: Transcatheter Aortic Valve Replacement
Heart Failure, Myocardial Infarction, Stroke, Acute Kidney Injury, Renal Insufficiency, Chronic, Arrhythmias, Cardiac, Cardiovascular
acute kidney injury, transcatheter aortic valve replacement, genomics, biomarker
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VITROS Immunodiagnostic Products NT-proBNP II

Amino Terminal pro-Brain Natriuretic Peptide (NTproBNP) is secreted in conditions of cardiac wall stress. NTproBNP levels are used in addition to clinical assessment to diagnose heart failure (HF). The purpose of this clinical study is to collect data to substantiate the use of the VITROS NT-proBNP II assay.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Deborah Diercks
152662
All
22 Years and over
This study is NOT accepting healthy volunteers
NCT03548909
STU 122017-045
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Acute HF Population (ED setting):
Inclusion Criteria:

• Subjects must have suspicion of HF and acute symptoms at presentation.
• Subjects must be at least 22 years of age.
• Subjects must be willing and able to provide informed consent.
Exclusion Criteria:

• Acute symptoms clearly not secondary to HF.
• Subjects with renal disease on dialysis.
• Subjects unable to comply with the study requirements. Population with suspicion of HF (Outpatient Setting):
Inclusion Criteria:

• Subjects must be at least 22 years of age.
• Subjects must be willing and able to provide informed consent.
• Subjects who present to outpatient centers with suspicion HF.
Exclusion Criteria:

• Symptoms clearly not secondary to HF.
• Subjects with renal disease on dialysis.
• Subjects unable to comply with the study requirements.
• Subjects previously diagnosed with heart failure.
Diagnostic Test: VITROS Immunodiagnostic Products
Heart Failure, Heart
NT-proBNP
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Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol (ADNI3)

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the study is to continue to discover, optimize, standardize, and validate clinical trial measures and biomarkers used in AD research.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Brendan Kelley
173025
All
55 Years to 90 Years old
N/A
This study is also accepting healthy volunteers
NCT02854033
STU 112016-068
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Inclusion Criteria (all CN participants): 1. Participant with or without subjective memory complaints, verified by a study partner, beyond what one would expect for age 2. Normal memory function documented by scoring above education adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale -Revised (the maximum score is 25): 1. 9 for 16 or more years of education 2. 5 for 8-15 years of education 3. 3 for 0-7 years of education 3. Mini-Mental State Exam score between 24 and 30 inclusive (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director) 4. Clinical Dementia Rating = 0. Memory Box score must be 0 5. Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living 6. Stability of Permitted Medications for at least 4 weeks: 1. Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years) 2. Estrogen replacement therapy is permissible 3. Gingko biloba is permissible, but discouraged 4. Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening. Inclusion Criteria (all MCI participants): 1. Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician. 2. Abnormal memory function documented by scoring below education adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale -Revised (the maximum score is 25): a. < 11 for 16 or more years of education b. ≤ 9 for 8-15 years of education c. ≤ 6 for 0-7 years of education 3. Mini-Mental State Exam score between 24 and 30 inclusive (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director) 4. Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5 5. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the Screening Visit 6. Stability of Permitted Medications for at least 4 weeks: 1. Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years) 2. Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to Screening Visit 3. Estrogen replacement therapy is permissible 4. Gingko biloba is permissible, but discouraged 5. Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening. Inclusion Criteria (all AD participants): 1. Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician.n. 2. Abnormal memory function documented by scoring below education adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale -Revised (the maximum score is 25): 1. ≤ 8 for 16 or more years of education 2. ≤ 4 for 8-15 years of education 3. ≤ 2 for 0-7 years of education 3. Mini-Mental State Exam score between 20 and 24 inclusive (Exceptions for scores of 24 and 25 may be made for participants with less than 8 years of education at the discretion of the Project Director) 4. Clinical Dementia Rating = 0.5 or 1.0 5. NINCDS (National Institute of Neurological and Communicative Disorders and Stroke) -ADRDA (Alzheimer's Disease and Related Disorders Association) criteria for probable AD 6. Stability of Permitted Medications for at least 4 weeks: 1. Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years) 2. Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to Screening Visit 3. Estrogen replacement therapy is permissible 4. Gingko biloba is permissible, but discouraged 5. Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening. Inclusion Criteria Specific to Newly Enrolled Participants 1. Geriatric Depression Scale score less than 6. 2. Age between 55-90 years (inclusive). 3. Study partner who has frequent contact with the participant (i.e., minimum average of 10 hours per week) and is available to accompany the participant to all clinic visits for the duration of the protocol. 4. Visual and auditory acuity adequate for neuropsychological testing. 5. Good general health with no diseases expected to interfere with the study. 6. Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile). 7. Willing and able to participate in a longitudinal imaging study. 8. Modified Hachinski Ischemic Score less than or equal to 4. 9. Completed six grades of education or has a good work history (sufficient to exclude mental retardation). 10. Must speak English or Spanish fluently. 11. Willing to undergo repeated MRIs (3Tesla) and at least two PET scans 12. Agrees to collection of blood for genomic analysis (including GWAS (genome-wide association study) sequencing and other analysis), APOE (Apolipoprotein E) testing and biospecimen banking. 13. Agrees to collection of blood for biomarker testing. 14. Agrees to at least one lumbar puncture for the collection of CSF. 15. Agrees to share genomic data and biomarker samples. Inclusion Criteria Specific to Rollover Participants" The following additional inclusion criteria apply to all diagnostic categories for rollover participants only: 1. Must have been enrolled and followed in ADNI-1, ADNI-GO, or ADNI-2 for at least one year. 2. Willing and able to continue to participate in an ongoing longitudinal study. A reduced battery of tests is allowable if the participant is not able/willing to complete the full battery. Exclusion Criteria (all CN participants): 1. Any significant neurologic disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities Exclusion Criteria (all MCI participants): 1. Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities. Exclusion Criteria (all AD participants): 1. Any significant neurologic disease other than Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities. Exclusion Criteria (all participants): The following additional exclusion criteria apply to all diagnostic categories: 1. Screening/Baseline MRI brain scan with evidence of infection, infarction, or other focal lesions or multiple lacunes or lacunes in a critical memory structure 2. Subjects that have any contraindications for MRI studies, including the presence of cardiac pacemakers, or metal fragments or foreign objects in the eyes, skin or body. 3. Major depression, bipolar disorder as described in DSM-IV within the past 1 year. Psychotic features, agitation or behavioral problems within the last 3 months that could lead to difficulty complying with the protocol. 4. Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder. 5. History of schizophrenia (DSM IV criteria). 6. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria). 7. Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol. 8. Clinically significant abnormalities in B12 or thyroid function tests (TFTs) that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant. 9. Residence in a skilled nursing facility. 10. Current use of specific psychoactive medications (e.g., certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics). Current use of warfarin or other anticoagulants such as dabigatran, rivaroxaban and apixaban (exclusionary for lumbar puncture). 11. Current use of any other exclusionary medications 12. Investigational agents are prohibited one month prior to entry and for the duration of the trial. 13. Participation in clinical studies involving neuropsychological measures being collected more than one time per year. Exclusion Criteria Specific to AV-1451 PET: The following criteria are exclusionary only for the AV-1451 scanning portion of the study: 1. History of risk factors for torsades de pointes (a cardiac dysrhythmia associated with sudden death) or taking medications known to prolong the QT interval. A list of restricted medications will be provided. 2. Have an ECG obtained prior to the AV-1451 PET scan that in the opinion of the investigator is clinically significant with regard to the subject's participation in the study. Bazett's corrected QT (QTcB) interval must be evaluated and must not exceed 458 msec in males, or 474 msec in females.
Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD), Brain and Nervous System
amyloid, plaques, neuroimaging, biomarkers, cognition disorder, early detection, pre-dementia, dementia, Alzheimer's disease, tau
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Precision Event Monitoring for Patients With Heart Failure Using HeartLogic (PREEMPT-HF)

The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator. There are no primary safety and/or efficacy endpoints for this study. Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet clinical need to slow the progression of Heart Failure and prevent hospitalizations. HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators, combines novel sensor parameters such as heart sounds and respiration with other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index for the early detection of worsening Heart Failure. However, there is limited data on the association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or for phenotyping the broad spectrum of Heart Failure patients.
Call 214-648-5005
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James Daniels
46951
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT03579641
STU 072018-065
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Inclusion Criteria:

• Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws.
• Subject has a documented diagnosis of heart failure.
• Subject has a Boston Scientific Cardiac Resynchronization Therapy Defibrillator or Implantable Cardioverter Defibrillator device implant that has HeartLogic, with Heart Failure Sensors turned ON, Respiratory Sensor turned ON, and Sleep Incline Sensor turned ON.
• Subject has an active bipolar right ventricle lead implant.
• Subject is enrolled in LATITUDE (NXT 5.0 or future version), and is willing to be remotely monitored from the baseline visit for approximately 12 months with HeartLogic disabled.
Exclusion Criteria:

• Subject has received or is scheduled to receive a heart transplant or ventricular assist device (VAD).
• Subject is enrolled in any concurrent clinical study without prior Boston Scientific written approval (excluding registries).
• Subject has a life expectancy of less than 12 months.
• Subject has a history of non-compliance to medical care or known inability to comply with requirements of the clinical study protocol
Device: HeartLogic Sensors
Heart Failure, Heart Disease, Cardiovascular Disease, Defibrillators, Implantable, Monitoring, Physiologic, Cardiac Resynchronization Therapy
Heart Failure, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Defibrillator, Heart Failure Sensor Data, 30-day Heart Failure Readmission, Ventricular Tachycardia/Ventricular Fibrillation Therapy, Non-Heart Failure Hospitalization, HeartLogic Feature, Latitude Remote Patient Monitor, Data Linkage, Sleep Incline Sensor, Respiratory Sensor, Decongestive Intravenous therapy, Decompensation
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