N-of-1 Trials In Children With Hypertension
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 10 - 22 |
| Updated: | 10/28/2018 |
| Start Date: | April 2, 2018 |
| End Date: | January 2020 |
| Contact: | Joyce P Samuel, MD, MS |
| Email: | joyce.samuel@uth.tmc.edu |
| Phone: | 713-500-6708 |
A Randomized Clinical Trial of the N-of-1 Approach in Children With Hypertension
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.
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.
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.
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.
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.
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
Phone: 713-500-5670
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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