A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects

July 7, 2025 updated by: Zona Health, Inc
The study will be a multi-center, randomized clinical trial to evaluate the safety and efficacy of using the Zona Plus handgrip therapy device compared to the use of an auditory relaxation therapy for treatment of high blood pressure and hypertension in subjects who are not currently taking antihypertensive medications. Half of the study subjects will also be randomized to record blood pressure at home throughout the study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study subjects randomized to the Zona Plus Device arm will perform isometric therapy with the device with subject compliance monitored through a downloadable electronic memory function built into the device. Study subjects randomized to the control arm will be asked to listen to relaxing music via a mobile app and asked to document their compliance via a patient diary. Subjects in the control arm may be able to crossover to using the Zona Plus device after completion of Study Visit 6. Subjects who have systolic blood pressure between 140mmHG and 149mmHG at baseline will complete three additional study visits for further monitoring. Subjects can expect participation in the study to last between 3 and 8 months.

Study Type

Interventional

Enrollment (Estimated)

160

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 Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Valley Village, California, United States, 91607
    • Florida
      • Coral Gables, Florida, United States, 33134
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Cedar Crosse Research Center
        • Contact:
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
    • Tennessee
      • Knoxville, Tennessee, United States, 37909

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject is male or female age 22 or older
  2. Diagnosed with elevated blood pressure or hypertension and verified during Visit #1 by standardized seated cuff SBP
  3. Have not taken antihypertensive medication for ≥30 days prior to the SEPV
  4. Subject is expected to have sufficient vision, hearing, and hand strength (hand strength is demonstrated by a maximum voluntary contraction (MVC) equaling 35 units of force in both hands measured by a dynamometer
  5. Subject has baseline BP measurements collected and completes study device training during Baseline Assessment (Visit #1);
  6. Subject agrees to maintain non-use of medications and over-the-counter (OTC) supplement regimen related to hypertension throughout the treatment phase;
  7. Patient can comply with and agrees to complete all required study procedures, study clinic visits, and associated activities;
  8. Patient must be able to understand and give written informed consent in the language provided;
  9. Subject must have SBP of 130 to ≤149 mmHg, if subjects present with SBP reading of ≥140mmHg they will receive heightened monitoring throughout the first month of the study

Exclusion Criteria:

  1. Subject is a female of childbearing potential (e.g., not postmenopausal for at least one year or has not had a hysterectomy or tubal ligation) not using medically effective birth control (e.g., hormonal methods in use at least 30 days prior to screening or barrier methods such as condom and spermicide in use at least 14 days prior to visit 1) or is pregnant, lactating, or plans to become pregnant during the study).
  2. BP ≥150 mmHg (systolic) and/or >90 mmHg (diastolic)
  3. A history of heart failure with current New York Heart Association (NYHA) class III- IV functional classification
  4. Currently has, or has had a history, of atrial fibrillation, in accordance with 2007 Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/European Cardiac Arrhythmia Society (ECAS) guidelines
  5. Patient has experienced 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
  6. A >10 mmHg difference in seated cuff SBP between the right and left arms collected during the SEPV;
  7. Unstable BP, 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 ;
  8. Arm circumference greater than 45 cm;
  9. Acute illness, infection, or inflammation
  10. Presence of any unstable cardiovascular disorder, such as MI, unstable angina, significant arrhythmia, stroke, or TIA; within the last six (6) months, or other serious comorbidity that would be likely to impact life expectancy to less than one (1) year or limit patient cooperation or study compliance;
  11. A history of rest or exertional angina pectoris in the previous six (6) months;
  12. History of solid organ transplant
  13. Any 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;
  14. 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;
  15. Patient has any other 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;
  16. Patients who currently own or have owned another Zona Plus device and are, or have been, voluntarily performing the isometric handgrip activities.
  17. Subject plans for greater than 10% of body weight loss/gain (10% of body weight over a 6-month period) during the study

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational
Zona Plus Device
Device: Zona Plus Device
Use of the Zona Plus device involves performing isometric handgrip exercise therapy. Isometric exercise is the type of exercise in which you tense or tighten your muscle without seeing it change in length.
Active Comparator: Control
Relaxing music
Other: Relaxing Music App
Relaxing music will be made available through a mobile app that users access via their smart phone or tablet. Subjects will have the option to listen to 5 different music genres that support relaxation (Classical, Nature, Movie Soundtracks, Jazz, Reggae).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare the change from baseline in mean seated cuff systolic blood pressure (SBP) after 10 weeks of treatment between patients randomized to the Zona Plus device and the patients in the control group.
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the change from baseline in seated cuff diastolic blood pressure ("DBP") after 10 weeks of treatment between patients randomized to the Zona Plus device and the patients in the control group.
Time Frame: 10 weeks
10 weeks
The percentage of patients randomized to the Zona Plus device who achieve a clinically significant SBP reduction (defined as ≥5 mmHg) at Week 10 compared to control.
Time Frame: 10 weeks
10 weeks
The percentage of patients randomized to the Zona Plus device who achieve a clinically significant DBP reduction (defined as ≥3 mmHg) at Week 10 compared to control.
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

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

Sponsor

Zona Health, Inc

Collaborators

Emergent Clinical Consulting, LLC

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)

March 27, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

February 25, 2025

Study Record Updates

Last Update Posted (Actual)

July 10, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zona-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Hypertension

Clinical Trials on Zona Plus Device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe