Hypertension | CAndesartan vs LIsinopril Effects on the BRain
Hypertension research study
What is the primary objective of this study?
The aim of this study is to conduct a 1-year double blind randomized control trial comparing candesartan to lisinopril in 140 individuals with hypertension and executive mild cognitive impairment in their effects on executive function, neuroimaging markers, and vascular indicators.
Who is eligible to participate?
Inclusion Criteria: 1. age: 55 years or older; 2. Hypertension: SBP≥140 mm Hg or DBP≥ 90 mm or receiving antihypertensive medications. 3. Executive MCI will be defined using these criteria: 1. The Montreal Cognitive Assessment (MoCA) score less than 26 2. Clinical Dementia Rating (CDR) score of 0.5, 3. Executive dysfunction: A performance at the 10th percentile or below on at least one of four screening tests for executive function: Trail Making Test, Part B (TMT-B), modified Stroop interference, verbal fluency (number of D words in 1 minute), or abstractions. Exclusion Criteria: 1. Intolerance to study drugs; 2. SBP >200 or DBP >110 mm Hg; 3. Renal disease or hyperkalemia 4. Active medical or psychiatric problems 5. Uncontrolled congestive heart failure; 6. History of stroke in the past 3 years; 7. Inability to perform the study procedures 8. Women of childbearing potential 9. diagnosis of dementia
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Mild Cognitive Impairment
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
CandesartanTo achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
LisinoprilTo achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Start Date: August 2014
Completed Date: December 3, 2018
Phase: Phase 3
Primary Outcome: Executive function (EXAMINER score)
Secondary Outcome: Perfusion and Vasoreactivity (VR)
Study sponsors, principal investigator, and references
Principal Investigator: Ihab Hajjar, MD, MS
Lead Sponsor: Ihab M. Hajjar
Collaborator: National Institute on Aging (NIA)