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NCT Number: NCT03461003

N-of-1 Trials 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 compared to usual care. This trial aims to 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.

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Key information

Conditions

Pediatric Hypertension

Age range

10 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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 compare the n-of-1 trial approach to usual care in normalizing blood pressure while minimizing exposure to compliance-reducing side effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NICHE method

Other

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

Other

Physician preference will dictate choice and adjustment of antihypertensive medication, BP measurement modality, interval between visits, and assessment of side effects.

Amlodipine

Drug

Calcium-channel blocker; antihypertensive

Lisinopril

Drug

Angiotensin-converting-enzyme (ACE) inhibitor; antihypertensive

Hydrochlorothiazide

Drug

Thiazide diuretic; antihypertensive

Losartan

Drug

Angiotensin II receptor blocker (ARB); antihypertensive

Primary outcomes

  1. Number of Participants With Ambulatory Blood Pressure (BP) Control at 6 Months

    Time frame: 6 months from enrollment

    Blood pressure control is when ambulatory blood pressure is normal, with normal as defined by the American Heart Association (AHA) criteria [the AHA criteria are systolic blood pressure and diastolic blood pressure (throughout wake and sleep) less than the 95th percentile based on the patient's gender and height]. To assess ambulatory blood pressure, participants wear a 24-hour blood pressure monitor, which records blood pressure at regular intervals throughout a 24-hour period.

Secondary outcomes

  1. Change in Mean 24-hour Ambulatory Systolic Blood Pressure

    Time frame: baseline, 6 months

    To assess 24-hour mean ambulatory blood pressure, participants wear a 24-hour blood pressure monitor, which records blood pressure at regular intervals throughout a 24-hour period, while awake and while asleep. The mean of all recordings over the 24-hour period is calculated per participant for both baseline and 6 months, and then the mean 24-hour systolic blood pressure at 6 months minus the mean 24-hour systolic blood pressure at baseline is calculated per participant. The average difference is reported, with a negative value indicating a reduction in blood pressure over time.

  2. Change in Mean Wake Ambulatory Systolic Blood Pressure

    Time frame: baseline, 6 months

    To assess mean wake ambulatory blood pressure, participants wear a 24-hour blood pressure monitor, which records blood pressure at regular intervals throughout a 24 hour period, throughout wake and sleep. The mean of all recordings that occur while the participant is awake during the 24-hour period is calculated for both baseline and 6 months, and then the mean wake systolic blood pressure at 6 months minus the mean wake systolic blood pressure at baseline is calculated per participant. The average difference is reported, with a negative value indicating a reduction in blood pressure over time.

  3. Number of Participants Who Reported That Side Effects From Medication Led Them to Discontinue Medication

    Time frame: from baseline to 6 months

  4. Number of Participants Who Self-reported Adherence to Intervention

    Time frame: from month 5 to month 6

    Adherence is reported as the number of participants who self-reported at the 6-month visit that they had not missed any doses of their medication in the preceding month.

  5. Patient Satisfaction With Intervention as Assessed by a Survey

    Time frame: 6 months

    Patient satisfaction is scored from 0 to 10, where 0 is the worst health care possible and 10 is the best health care possible.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

A Randomized Clinical Trial of the N-of-1 Approach in Children With Hypertension

Acronym: NICHE

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Mar 9, 2018
Registry last updated
Sep 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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