A Pivotal Study To Evaluate The Effectiveness of Isometric Handgrip Therapy In Prehypertensive And Hypertensive Patients
- Conditions
- Hypertension, Systolic
- Interventions
- Device: Zona Plus DeviceDevice: Control Device
- Registration Number
- NCT04467879
- Lead Sponsor
- Zona Health, Inc
- Brief Summary
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
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").
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 146
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zona Plus - Active - "Normal Grip" Zona Plus Device 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. Control Device - Sham - "Weaker Grip" Control Device 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.
- Primary Outcome Measures
Name Time Method Change from Baseline in Systolic Blood Pressure to Day 70 ± 2 Days 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.
- Secondary Outcome Measures
Name Time Method Comparison of Heart Rate between Zona Plus nominal device and Placebo controlled device Change from Baseline to Day 160 ± 4 Days 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 in Diastolic Blood Pressure to Day 70 ± 2 Days Change from Baseline 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").
Percentage change from Baseline in Systolic Blood Pressure reduction at Day 70 ± 2 Days Change from Baseline to 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.
Percentage change from Baseline in Diastolic Blood Pressure reduction at Day 70 ± 2 Days Change from Baseline to 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.
Percentage change from Baseline in Systolic Blood Pressure reduction at Day 160 ± 4 Days Change from Baseline to 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
Percentage change in Diastolic Blood Pressure reduction at Day 160 ± 4 Days Change from Baseline to 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
Trial Locations
- Locations (5)
Goldsboro Medical Center
🇺🇸Goldsboro, North Carolina, United States
Saint Louis Heart & Vascular, P.C.
🇺🇸Saint Louis, Missouri, United States
Carolinas Research Center LLC
🇺🇸Charlotte, North Carolina, United States
Sante Clinical Research
🇺🇸Kerrville, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States