A Pivotal Study To Evaluate The Effectiveness of Isometric Handgrip Therapy In Prehypertensive And Hypertensive Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 146
- 试验地点
- 10
- 主要终点
- Change from Baseline in Systolic Blood Pressure to Day 70 ± 2 Days
研究概览
简要总结
This is a double-blind, sham-controlled clinical trial assessing the effectiveness of personalized isometric handgrip device therapy. Approximately 230 patients who present with a Systolic Blood Pressure reading of ≤ 149mmHg and who have not taken any antihypertensive medication for more than 30 days will be enrolled.
详细描述
This study is designed to examine the effectiveness of individualized isometric handgrip device therapy in prehypertension or hypertension patient subjects who are not at target BP and who are naive to anti-hypertensive medication for at least 30 days before screening. The investigational plan examines changes in blood pressure (BP) in up to 230 patient subjects who are randomized to either the "active" (i.e., the Zona Plus device proposed for marketing), or to a "sham" device (which is intentionally calibrated for a "weaker grip").
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double Blinded
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from Baseline in Systolic Blood Pressure to Day 70 ± 2 Days
时间窗: Change from Baseline to Day 70 ±2 Days
Comparative assessment in the change from Baseline in seated cuff Systolic Blood Pressure after ten(10) weeks of treatment between patients treated with the Zona Plus nominal device ("stronger grip") and patients treated with the Placebo control device ("weaker grip"). A reduction in Systolic Blood ≥ 5 Preassure after 10 weeks of treatment is considered to be a better outcome.
次要结局
- Comparison of Heart Rate between Zona Plus nominal device and Placebo controlled device(Change from Baseline to Day 160 ± 4 Days)
- Change from Baseline in Diastolic Blood Pressure to Day 70 ± 2 Days(Change from Baseline to Day 70 ±2 Days)
- Percentage change from Baseline in Systolic Blood Pressure reduction at Day 70 ± 2 Days(Change from Baseline to Day 70 ± 2 Days)
- Percentage change from Baseline in Diastolic Blood Pressure reduction at Day 70 ± 2 Days(Change from Baseline to Day 70 ± 2 Days)
- Percentage change in Diastolic Blood Pressure reduction at Day 160 ± 4 Days(Change from Baseline to Day 160 ± 4 Days)
- Percentage change from Baseline in Systolic Blood Pressure reduction at Day 160 ± 4 Days(Change from Baseline to Day 160 ± 4 Days)