A Randomized Clinical Trial of the N-of-1 Approach in Children With Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Number of Participants With Ambulatory Blood Pressure (BP) Control at 6 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treating physician determines that pharmacologic therapy is indicated for treatment of hypertension
- •ambulatory hypertension has been confirmed (off meds) within 12 months of enrollment
排除标准
- •age < 10 years
- •resistant hypertension (requiring ≥ 3 drug therapy)
- •absolute contraindication or allergy to any of the tested drugs.
研究组 & 干预措施
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.
干预措施: NICHE method (Other)
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.
干预措施: Amlodipine (Drug)
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.
干预措施: Lisinopril (Drug)
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.
干预措施: Hydrochlorothiazide (Drug)
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.
干预措施: Losartan (Drug)
Usual Care
No protocol will be introduced to standardize BP management in the control arm.
干预措施: Usual care (Other)
结局指标
主要结局
Number of Participants With Ambulatory Blood Pressure (BP) Control at 6 Months
时间窗: 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.
次要结局
- Patient Satisfaction With Intervention as Assessed by a Survey(6 months)
- Number of Participants Who Reported That Side Effects From Medication Led Them to Discontinue Medication(from baseline to 6 months)
- Change in Mean 24-hour Ambulatory Systolic Blood Pressure(baseline, 6 months)
- Number of Participants Who Self-reported Adherence to Intervention(from month 5 to month 6)
- Change in Mean Wake Ambulatory Systolic Blood Pressure(baseline, 6 months)
研究者
Joyce Philip Samuel
Assistant Professor of Pediatrics
The University of Texas Health Science Center, Houston