A Pivotal Study To Evaluate The Effectiveness of Isometric Handgrip Therapy In Prehypertensive And Hypertensive Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A Pivotal Study To Evaluate The Effectiveness of Isometric Handgrip Therapy In Prehypertensive And Hypertensive Patients

Conditions
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Hypertension, Systolic

Intervention / Treatment
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* Device: Zona Plus Device
* Device: Control Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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 Exclusion Criteria 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, double-blinded, randomized, sham-controlled study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zona Plus - Active - Normal Grip<br>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. | Device: Zona Plus Device<br>* Zona Plus 3.0 Individualized Isometric Handgrip Therapy Device<br>* Other names: Zona Plus 3.0;|
| Sham Comparator: Control Device - Sham - Weaker Grip<br>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. | Device: Control Device<br>* Zona Plus control sham device, with a nominal weaker grip<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Systolic Blood Pressure 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. | Change from Baseline to Day 70 ±2 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Diastolic Blood Pressure to Day 70 ± 2 Days | Comparative assessment of the change from Baseline in seated cuff Diastolic Blood Pressure after 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). | Change from Baseline to Day 70 ±2 Days | 
| Percentage change from Baseline in Systolic Blood Pressure reduction at Day 70 ± 2 Days | Comparative assessment in the percentage of patients who achieve a clinically significant Systolic Blood Pressure reduction (defined as ≥ 5 mmHg) 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 | Comparative assessment in the percentage of patients who achieve a clinically significant Diastolic Blood Pressure reduction (defined as ≥3 mmHg) at Day 70 ± 2 Days. | Change from Baseline to Day 70 ± 2 Days | 
| Percentage change from Baseline in Systolic Blood Pressure reduction at Day 160 ± 4 Days | Comparative assessment in change from Baseline in the seated cuff Systolic Blood Pressure after 6 months Day 160 ± 4 of treatment between patients treated with the Zona Plus nominal device and patients treated with the Placebo control device. | Change from Baseline to Day 160 ± 4 Days | 
| Percentage change in Diastolic Blood Pressure reduction at Day 160 ± 4 Days | Comparative assessment in change from Baseline in the seated cuff Diastolic Blood Pressure after 6 months Day 160 ± 4 Days of treatment between patients treated with the Zona Plus nominal device and patients treated with the Placebo control device. | Change from Baseline to Day 160 ± 4 Days | 
| Percentage change from Baseline in Systolic Blood Pressure reduction at Day 160 ± 4 Days | Comparative assessment in the percentage of patients who achieve a clinically significant Systolic Blood Pressure reduction (defined as ≥ 5 mmHg) at Day 160 ± 4 Days | Change from Baseline to Day 160 ± 4 Days | 
| Percentage change in Diastolic Blood Pressure reduction at Day 160 ± 4 Days | Comparative assessment in the percentage of patients who achieve a clinically significant Diastolic Blood Pressure reduction defined as ≥3 mmHg 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 | The Heart Rate (HR) will be recorded and compared between the Zona Plus nominal device and the Placebo control device treatment groups. | Change from Baseline to Day 160 ± 4 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diastolic Hypertension, HandGrip Therapy, Pre-Hypertension, Isometric Exercise, Vascular Hypertension