Purpose

The single patient (n-of-1) randomized trial is an underused approach to resolving therapeutic uncertainty by using a patient's own data to inform an individualized treatment plan. The proposed research is designed to assess whether the n-of-1 trial approach improves blood pressure control. This trial will advance learning about not only the treatment of pediatric hypertension but also the use of a neglected type of randomized trial to optimize the care of each patient.

Condition

Eligibility

Eligible Ages
Between 10 Years and 22 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • treating physician determines that pharmacologic therapy is indicated for treatment of hypertension
  • ambulatory hypertension has been confirmed (off meds) within 12 months of enrollment

Exclusion Criteria

  • age < 10 years
  • resistant hypertension (requiring ≥ 3 drug therapy)
  • absolute contraindication or allergy to any of the tested drugs.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Amlodipine
    Calcium-channel blocker; antihypertensive
  • Drug: Lisinopril
    Angiotensin-converting-enzyme (ACE) inhibitor; antihypertensive
  • Drug: Hydrochlorothiazide
    Thiazide diuretic; antihypertensive
  • Drug: Losartan
    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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Joyce P Samuel, MD, MS
713-500-5670
joyce.p.samuel@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Joyce P Samuel, MD, MS
713-500-6708
joyce.samuel@uth.tmc.edu

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.