Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
49 participants
INTERVENTIONAL
2018-04-02
2021-05-02
Brief Summary
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Detailed Description
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Large parallel-group, comparative effectiveness trials are likely not on the horizon for this population. Moreover, heterogeneity of treatment effects would minimize the generalizability of such a trial to all patients.
This is a parallel-group, randomized clinical trial to compare the n-of-1 trial approach to usual care in normalizing blood pressure while minimizing exposure to compliance-reducing side effects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NICHE method
In the NICHE method, antihypertensive therapy will be chosen using an n-of-1 trial to identify the preferred therapy. Preferred therapy is defined a priori as that which produces the greatest reduction in ambulatory BP without intolerable side effects. Tested drugs will include amlodipine or losartan, lisinopril, and hydrochlorothiazide.
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.
Amlodipine
Calcium-channel blocker; antihypertensive
Lisinopril
Angiotensin-converting-enzyme (ACE) inhibitor; antihypertensive
Hydrochlorothiazide
Thiazide diuretic; antihypertensive
Losartan
Angiotensin II receptor blocker (ARB); antihypertensive
Usual Care
No protocol will be introduced to standardize BP management in the control arm.
Usual care
Physician preference will dictate choice and adjustment of antihypertensive medication, BP measurement modality, interval between visits, and assessment of side effects.
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* ambulatory hypertension has been confirmed (off meds) within 12 months of enrollment
Exclusion Criteria
* resistant hypertension (requiring ≥ 3 drug therapy)
* absolute contraindication or allergy to any of the tested drugs.
10 Years
22 Years
ALL
No
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
NIH
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Joyce Philip Samuel
Assistant Professor of Pediatrics
Principal Investigators
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Joyce P. Samuel, MD, MS
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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References
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Flynn JT, Daniels SR, Hayman LL, Maahs DM, McCrindle BW, Mitsnefes M, Zachariah JP, Urbina EM; American Heart Association Atherosclerosis, Hypertension and Obesity in Youth Committee of the Council on Cardiovascular Disease in the Young. Update: ambulatory blood pressure monitoring in children and adolescents: a scientific statement from the American Heart Association. Hypertension. 2014 May;63(5):1116-35. doi: 10.1161/HYP.0000000000000007. Epub 2014 Mar 3. No abstract available.
Samuel JP, Bell CS, Samuels JA, Rajan C, Walton AK, Green C, Tyson JE. N-of-1 Trials vs. Usual Care in Children With Hypertension: A Pilot Randomized Clinical Trial. Am J Hypertens. 2023 Feb 13;36(2):126-132. doi: 10.1093/ajh/hpac117.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-MS-17-1014
Identifier Type: -
Identifier Source: org_study_id
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