Hypertension in Young Adults Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Achieved systolic blood pressure
研究概览
简要总结
This is a pilot randomized controlled trial which will test the effect of 3 different anti-hypertensive agents and 3 different strategies of engaging young adults in home blood pressure monitoring on blood pressure control, with secondary outcomes focused on quality of life and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-40 years of age
- •Diagnosis of hypertension or receiving anti-hypertensive therapy OR Has clinical BP readings >130/80 mmHg that would meet the definition of hypertension and have home BP readings >=125/80 mmHg
排除标准
- •are or are planning to become pregnant, due to inability to take multiple classes of anti- hypertensive agents
- •are marginally housed, due to concerns regarding routine follow-up
- •are actively participating in a different interventional trial that may affect blood pressure
- •are unwilling to consent to participate
- •institutionalized individuals or prisoners
- •are actively abusing illicit drugs or alcohol
- •have a history of poor or doubtful compliance (e.g., frequently missed appointments)
- •have cognitive impairment prohibiting participation in the study
- •History of allergy to any of the randomized medications
- •Serum potassium >5.5 meq/L at the screening visit
- •BP > 160/100 mmHg in clinic (stage II hypertension), regardless of whether patient is on therapy
- •eGFR < 30 mL/min/1.73 m2
研究组 & 干预措施
Amlodipine 2.5 mg + Home BP monitoring with cuffed device
Use of at least the minimum dose of amlodipine and use of a home BP monitoring device for BP monitoring
干预措施: Home BP monitoring with cuffed device (Device)
Chlorthalidone 12.5 mg + Home BP monitoring with cuffed device
Use of at least the minimum dose of chlorthalidone and use of a home BP monitoring device for BP monitoring
干预措施: Home BP monitoring with cuffed device (Device)
Losartan 12.5 mg daily + home BP monitoring with cuffed device
Use of at least the minimum dose of losartan and use of a home BP monitoring cuffed device only for BP monitoring
干预措施: Home BP monitoring with cuffed device (Device)
amlodipine 2.5 mg daily + home BP monitoring with patch
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring
干预措施: Home BP monitoring with cuffed device + BP patch (Device)
Chlorthalidone 12.5 mg daily + home BP monitoring with patch
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring
干预措施: Home BP monitoring with cuffed device + BP patch (Device)
Losartan 12.5 mg daily + home BP monitoring with patch
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring
干预措施: Home BP monitoring with cuffed device + BP patch (Device)
amlodipine 2.5 mg daily + home BP monitoring with watch
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring
干预措施: Home BP monitoring with cuffed device + BP watch (Device)
chlorthalidone 12.5 mg daily + home BP monitoring with watch
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring
干预措施: Home BP monitoring with cuffed device + BP watch (Device)
losartan 12.5 mg daily + home BP monitoring with watch
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring
干预措施: Home BP monitoring with cuffed device + BP watch (Device)
Amlodipine 2.5 mg + Home BP monitoring with cuffed device
Use of at least the minimum dose of amlodipine and use of a home BP monitoring device for BP monitoring
干预措施: Anti-hypertensive agent: amlodipine (Drug)
Chlorthalidone 12.5 mg + Home BP monitoring with cuffed device
Use of at least the minimum dose of chlorthalidone and use of a home BP monitoring device for BP monitoring
干预措施: Anti-hypertensive agent: Chlorthalidone (Drug)
Losartan 12.5 mg daily + home BP monitoring with cuffed device
Use of at least the minimum dose of losartan and use of a home BP monitoring cuffed device only for BP monitoring
干预措施: Anti-hypertensive agent: Losartan (Drug)
amlodipine 2.5 mg daily + home BP monitoring with patch
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring
干预措施: Anti-hypertensive agent: amlodipine (Drug)
Chlorthalidone 12.5 mg daily + home BP monitoring with patch
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring
干预措施: Anti-hypertensive agent: Chlorthalidone (Drug)
Losartan 12.5 mg daily + home BP monitoring with patch
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a patch for BP monitoring
干预措施: Anti-hypertensive agent: Losartan (Drug)
amlodipine 2.5 mg daily + home BP monitoring with watch
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring
干预措施: Anti-hypertensive agent: amlodipine (Drug)
chlorthalidone 12.5 mg daily + home BP monitoring with watch
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring
干预措施: Anti-hypertensive agent: Chlorthalidone (Drug)
losartan 12.5 mg daily + home BP monitoring with watch
Use of at least the minimum dose of this agent and use of a home BP monitoring device only + a watch for BP monitoring
干预措施: Anti-hypertensive agent: Losartan (Drug)
结局指标
主要结局
Achieved systolic blood pressure
时间窗: Month 6
Systolic blood pressure will be collected using at home cuffed devices. The readings at end of the pilot trial (or most recent readings available) will be used for analysis of the primary outcome.
次要结局
- Adherence to home BP monitoring(Between month 0 and 6)