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

September 19, 2022 updated by: Zona Health, Inc
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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").

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63044
        • Saint Louis Heart & Vascular, P.C.
    • North Carolina
      • Charlotte, North Carolina, United States, 28215
        • Carolinas Research Center LLC
      • Goldsboro, North Carolina, United States, 27534
        • Goldsboro Medical Center
    • Texas
      • Kerrville, Texas, United States, 78028
        • Sante Clinical Research
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Zona Plus Device
Zona Plus 3.0 Individualized Isometric Handgrip Therapy Device
Other Names:
  • Zona Plus 3.0
Sham Comparator: 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.
Device: Control Device
Zona Plus control sham device, with a nominal weaker grip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Systolic Blood Pressure to Day 70 ± 2 Days
Time Frame: 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.
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
Time Frame: 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").
Change from Baseline to Day 70 ±2 Days
Percentage change from Baseline in Systolic Blood Pressure reduction at Day 70 ± 2 Days
Time Frame: 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.
Change from Baseline to Day 70 ± 2 Days
Percentage change from Baseline in Diastolic Blood Pressure reduction at Day 70 ± 2 Days
Time Frame: 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.
Change from Baseline to Day 70 ± 2 Days
Percentage change from Baseline in Systolic Blood Pressure reduction at Day 160 ± 4 Days
Time Frame: Change from Baseline to 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
Time Frame: Change from Baseline to 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
Time Frame: 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
Change from Baseline to Day 160 ± 4 Days
Percentage change in Diastolic Blood Pressure reduction at Day 160 ± 4 Days
Time Frame: 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
Change from Baseline to Day 160 ± 4 Days
Comparison of Heart Rate between Zona Plus nominal device and Placebo controlled device
Time Frame: 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 to Day 160 ± 4 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zona Health, Inc

Collaborators

Research & Development Concierge Company

Investigators

  • Study Chair: Mark Young, Zona Health, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

September 13, 2022

Study Completion (Actual)

September 14, 2022

Study Registration Dates

First Submitted

July 8, 2020

First Submitted That Met QC Criteria

July 8, 2020

First Posted (Actual)

July 13, 2020

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

If in the future Investigators want to access the data for secondary analysis they can submit a request from the Sponsor or R&D Data Management Contact. Individual patient data will not be shared by the sponsor directly and will be aggregated, monitored, and de-identified (APD) via 1) final approved clinical study report 2) any manuscripts or summary results report via an email request to the central contact once database lock has occurred and reports are generated.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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