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
- 5
- 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
- •Male or female of any ethnicity between 18 and 80 years of age
- •Diagnosed with prehypertension or hypertension and verified during the Baseline visit
- •Non-use of antihypertensive medication for ≥30 prior to screening
- •Currently not taking any antihypertensive medications or decline to take any antihypertensive medications(e.g., diuretic, angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), ] beta-blocker (BB), renin inhibitor (RI), calcium channel blocker (CCB) or alpha-adrenergic agonist (clonidine))
- •Sufficient vision with the patient able to see the screen prompts on the device, sufficient hearing with the patient able to hear the device audio prompts, sufficient hand strength (demonstrated by a maximum voluntary contraction equaling 35 units of force in both hands measured by the device)
- •Baseline Blood Pressure measurements collected and study device training completed during the Baseline visit
- •Non-use of medications and over the counter (OTC)supplement regimen related to hypertension throughout the study duration
- •Only one patient per household can participate in the study, eliminating the potential of unblinding
- •Able to comply with study procedures and agrees to complete all required study visits and associated activities
- •Ability to give written informed consent in either English, Spanish or French •≤149 mmHg, Systolic Blood Pressure wherein patients who present with Systolic Blood Pressure readings ≥140 mmHg will receive heightened monitoring throughout the first month of the study
排除标准
- •Pregnant or not using adequate contraception
- •Blood Pressure ≥150 mmHg (systolic) and/or >90 mmHg (diastolic)
- •History of heart failure
- •Hospitalization due to a hypertensive emergency, with impending or progressive target organ dysfunction (i.e., renal dysfunction, left ventricular hypertrophy or CNS involvement) within the past six (6) months
- •>10 mmHg difference in Systolic Blood Pressure between the right and left arms collected during screening
- •Unstable Blood Pressure, defined as >5 mmHg variance between any two (2) consecutive weekly readings (with a maximum of four (4) attempts) to determine a baseline BP measurement
- •Arm circumference greater than 45cm
- •Acute illness, infection, or inflammation
- •Unstable cardiovascular disorder, such as MI, unstable angina, significant arrhythmia, stroke, or TIA within the last six (6)months, or other serious comorbidity impacting life expectancy to < than a 1 year
- •Rest or exertional angina pectoris in the previous six (6) months
- •History of solid organ transplant
- •Secondary form of hypertension (HTN) etiology, including but not limited to primary aldosteronism, chronic steroid therapy and Cushing syndrome, pheochromocytoma, aorta coarctation or untreated thyroid or parathyroid disease
- •Concurrent participation in an investigational clinical study that has not completed the follow-up period or planned participation in another study within the next six(6) months
- •Any condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete, good quality data or the completion of the research study
- •Currently own or have owned another Zona Plus device and are,or have been,voluntarily performing the isometric handgrip activities.
研究组 & 干预措施
Zona Plus - Active - "Normal Grip"
Using the Zona Plus Device, the patient will perform a twelve-minute isometric handgrip therapy session at approximately the same time each day . After an initial handgrip strength assessment (the session calibration), a two-minute isometric routine is performed four times, two sessions per hand, with a one-minute non-grip, or rest session between each isometric routine.
干预措施: Zona Plus Device (Device)
Control Device - Sham - "Weaker Grip"
Using the Zona Sham Control Device the patient will perform a twelve-minute isometric handgrip therapy session at approximately the same time each day. After an initial handgrip strength assessment (the calibration), a two-minute isometric routine is performed four times, two sessions per hand, with a one-minute non-grip, or rest session between each isometric routine.
干预措施: Control Device (Device)
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
- 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)
- 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)