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Hypertension, Intracranial Pulsatility and Brain Amyloid-beta Accumulation in Older Adults (HIPAC Trial) (HIPAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03354143
Recruitment Status : Active, not recruiting
First Posted : November 27, 2017
Last Update Posted : August 15, 2022
Sponsor:
Collaborators:
Texas Health Resources
Michigan State University
Information provided by (Responsible Party):
Rong Zhang, University of Texas Southwestern Medical Center

Study Description
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Brief Summary:

The aim of this study is to determine if lowering blood pressure using FDA approved medication (antihypertensive drugs) alters brain pulsatility and reduces brain amyloid beta protein accumulation in older adults. Amyloid beta protein is high in the brain of older adults with Alzheimer's disease. Hypertension may increase brain amyloid beta protein accumulation and affect memory and thinking ability in older adults. However, whether lowering blood pressure reduces brain amyloid beta protein and improves brain function is inconclusive.

The investigators hypothesize that treating high blood pressure alters brain pulsatility, which in turn reduces brain amyloid beta protein accumulation and improves brain structure and function.


Condition or disease Intervention/treatment Phase
Hypertension Drug: Standard Care Drug: Intensive Treatment Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hypertension, Intracranial Pulsatility and Brain Amyloid-beta Accumulation in Older Adults (HIPAC Trial)
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Care
Subjects in the standard care arm will receive calcium channel blocker (CCB, amlodipine), angiotensin II receptor blocker (ARB, losartan), and other antihypertensive drugs to reduce 24-hour SBP ≤ 130 mmHg. Drug doses will be titrated to reach the BP target.
 Drug: Standard Care
Calcium channel blocker (CCB, amlodipine), angiotensin II receptor blocker (ARB, losartan), and other antihypertensive drugs will be used to reduce 24-hour SBP ≤ 130 mmHg.
Experimental: Intensive Treatment
Subjects in the intensive treatment arm will receive calcium channel blocker (CCB, amlodipine), angiotensin II receptor blocker (ARB, losartan), and other antihypertensive drugs to reduce 24-hour SBP ≤ 120 mmHg.
 Drug: Intensive Treatment
Calcium channel blocker (CCB, amlodipine), angiotensin II receptor blocker (ARB, losartan), and other antihypertensive drugs will be used to reduce 24-hour SBP ≤ 120 mmHg.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in intracranial pulsatility [ Time Frame: Baseline and 12-months ]
    Changes in intracranial pulsatility will be measured with CINE phase-contrast MRI


Secondary Outcome Measures :
  1. Cerebrospinal fluid Amyloid-β and tau [ Time Frame: Baseline and 12-months ]
  2. Global and regional brain perfusion via Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline and 12-months ]
  3. Regional brain volume via Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline and 12-months ]
  4. Regional cortical thickness via Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline and 12-months ]
  5. Brain white matter hyperintensity (WMH) via Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline and 12-months ]
  6. Brain white matter microstructural integrity via Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline and 12-months ]
  7. Brain neural network functional connectivity via Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline and 12-months ]
  8. NIH-Toolbox neurocognitive function [ Time Frame: Baseline, 6-months,12-months ]
  9. NIH PROMIS patient-reported outcome measures of physical health [ Time Frame: Baseline, 6-months, 12-months ]
  10. NIH PROMIS patient-reported outcome measures of mental health [ Time Frame: Baseline, 6-months, 12-months ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 55-79, all races/ethnicities, and both women and men are eligible;
  2. Mini-mental state exam (MMSE) > 26 to exclude cognitive impairment or dementia;
  3. Healthy normotensive subjects (24-hour ambulatory BP<125/75 mmHg without use of antihypertensive medication);
  4. Patients with hypertension defined as 24-hour SBP ≥130 mmHg , patients on BP medications are eligible;
  5. Patients with hypertension are willing to be randomized into either treatment group and ability to return to clinic or laboratory for follow-up visits over 12 months;
  6. Fluency in English, adequate visual and auditory acuity to allow neuropsychological testing;
  7. Screening laboratory tests and ECG without significant abnormalities that might interfere with the study

Exclusion Criteria:

  1. History of stroke, transient ischemic attack, traumatic brain injury or severe cerebrovascular disease by clinical diagnosis or past MRI/CT;
  2. Diagnosis of AD or other type of dementia and neurodegenerative diseases;
  3. Evidence of severe depression or other DSM-V Axis I psychopathology
  4. Unstable heart disease based on clinical judgment (heart attack/cardiac arrest, cardiac bypass procedures within previous 6 months and congestive heart failure), evidence of atrial fibrillation on ECG, or other severe medical conditions;
  5. Chronic kidney diseases with GFR < 40 ml/min;
  6. Orthostatic hypotension, defined as standing SBP<100 mmHg;
  7. History of significant autoimmune disorders such as systemic lupus erythematosus, rheumatoid arthritis and polymyalgia rheumatica;
  8. History of drug or alcohol abuse within the last 2 years;
  9. Diagnosis of uncontrolled diabetes mellitus (fasting blood sugar ≥126 mg/dL or A1C >7.5%)
  10. Obstructive sleep apnea;
  11. Regularly smoking cigarette within the past year;
  12. Severe obesity with BMI ≥ 45;
  13. Participants enrolled in another investigational drug or device study within the past 2 months;
  14. Carotid stent or sever stenosis (> 50%);
  15. Pacemaker or other medical device of metal that precludes performing MRI;
  16. History of B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowable);
  17. Any conditions judged by the study investigators to be either medically inappropriate, or risky for participant or likely to have poor study adherence;
  18. Claustrophobia;
  19. Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354143


Locations
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United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Texas Health Resources
Michigan State University
Investigators
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Principal Investigator: Rong Zhang, PhD University of Texas Southwestern Medical Center and Texas Health Resources
Principal Investigator: Wanpen Vongpatanasin, MD University of Texas Southwestern Medical Center
Principal Investigator: David Zhu, PhD Michigan State University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rong Zhang, Professor of Neurology, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03354143    
Other Study ID Numbers: R01AG057571 ( U.S. NIH Grant/Contract )
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: August 15, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared approximately 18-24 months after the primary study publication.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rong Zhang, University of Texas Southwestern Medical Center:
Dementia
Alzheimer's Disease
Blood Pressure
Cognitive Function
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Intracranial Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases