N-of-1 Trials In Children With Hypertension (NICHE)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03461003|
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : October 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Hypertension||Other: NICHE method Other: Usual care Drug: Amlodipine Drug: Lisinopril Drug: Hydrochlorothiazide Drug: Losartan||Phase 4|
Pediatric hypertension, a growing problem, often requires prescription of antihypertensive medication. Pediatric hypertension specialists lack an evidentiary base on which to establish definitive clinical practice guidelines for first-line therapy. Significant practice variation is an unsurprising consequence. Routine choice of the same first-line therapy for most patients with hypertension, absent testing other options, may delay correction of blood pressure for months or years. Failure to incorporate patient preferences in medical decision-making may also contribute to decreased patient satisfaction and adherence.
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 test whether the n-of-1 trial approach is superior to usual care in normalizing blood pressure while minimizing exposure to compliance-reducing side effects.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Clinical Trial of the N-of-1 Approach in Children With Hypertension|
|Actual Study Start Date :||April 2, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: NICHE method
In the NICHE method, antihypertensive therapy will be chosen using an n-of-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.
Other: 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.
Calcium-channel blocker; antihypertensive
Angiotensin-converting-enzyme (ACE) inhibitor; antihypertensive
Thiazide diuretic; antihypertensive
Angiotensin II receptor blocker (ARB); antihypertensive
Active Comparator: Usual Care
No protocol will be introduced to standardize BP management in the control arm.
Other: Usual care
Physician preference will dictate choice and adjustment of antihypertensive medication, BP measurement modality, interval between visits, and assessment of side effects.
- Ambulatory blood pressure (BP) control [ Time Frame: 6 months from enrollment ]Normal ambulatory blood pressure by American Heart Association criteria
- Ambulatory BP reduction from baseline [ Time Frame: 6 months ]Wake mean systolic BP (baseline) minus wake mean systolic BP (6 months)
- Side effect experience [ Time Frame: 6 months ]Questionnaire regarding overall experience with side effects on current medication
- Cost-effectiveness [ Time Frame: 6 months ]Evaluate the cost-effectiveness of the N-of-1 trial relative to usual care expressed as the incremental health system costs per additional normotensive child. Hypothesis: The N-of-1 trial will be deemed cost effective if it leads to either an increase in BP control without an increase in health system costs, a reduction in costs without a decrease in BP control, or both a reduction in costs with BP control improvement.
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): NCT03461003
|Contact: Joyce P Samuel, MD, MSemail@example.com|
|Contact: Deborah Garciafirstname.lastname@example.org|
|United States, Texas|
|The University of Texas Health Science Center at Houston||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Joyce P Samuel, MD, MS 713-500-5670 email@example.com|
|Principal Investigator:||Joyce P. Samuel, MD, MS||The University of Texas Health Science Center, Houston|