49
Participants
Start Date
April 2, 2018
Primary Completion Date
November 14, 2020
Study Completion Date
May 2, 2021
NICHE method
Based on underlying comorbidities at enrollment, patients will be assigned to either an unrestricted protocol (amlodipine versus lisinopril) or a restricted protocol (losartan versus lisinopril). Two drugs are tested in randomized order. Failure to achieve BP control at maximum doses of the first two drugs will result in augmentation with a diuretic (hydrochlorothiazide). BP control is assessed with 24 hour ambulatory monitoring at the end of each 2 week treatment period. Side effect tolerability is assessed with a questionnaire.
Usual care
Physician preference will dictate choice and adjustment of antihypertensive medication, BP measurement modality, interval between visits, and assessment of side effects.
Amlodipine
Calcium-channel blocker; antihypertensive
Lisinopril
Angiotensin-converting-enzyme (ACE) inhibitor; antihypertensive
Hydrochlorothiazide
Thiazide diuretic; antihypertensive
Losartan
Angiotensin II receptor blocker (ARB); antihypertensive
The University of Texas Health Science Center at Houston, Houston
National Center for Advancing Translational Sciences (NCATS)
NIH
The University of Texas Health Science Center, Houston
OTHER