Elevated Blood PressureNCT06843577
A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects
A study testing Zona Plus Device and Relaxing Music App in people with Elevated Blood Pressure and Hypertension, run by Zona Health, Inc at 10 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Elevated Blood Pressure, Hypertension
- What is being tested?
- Zona Plus Device and Relaxing Music App
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 10 sitesUnited States
- Study dates
- 27 Mar 2025to Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is male or female age 22 or older
- Diagnosed with elevated blood pressure or hypertension and verified during Visit #1 by standardized seated cuff SBP
- Have not taken antihypertensive medication for ≥30 days prior to the SEPV
- 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
- Subject has baseline BP measurements collected and completes study device training during Baseline Assessment (Visit #1);
- Subject agrees to maintain non-use of medications and over-the-counter (OTC) supplement regimen related to hypertension throughout the treatment phase;
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- Patient can comply with and agrees to complete all required study procedures, study clinic visits, and associated activities;
- Patient must be able to understand and give written informed consent in the language provided;
- 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
Who cannot join
- 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).
- BP ≥150 mmHg (systolic) and/or >90 mmHg (diastolic)
- A history of heart failure with current New York Heart Association (NYHA) class III- IV functional classification
- 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
- 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
- A >10 mmHg difference in seated cuff SBP between the right and left arms collected during the SEPV;
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- 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 ;
- Arm circumference greater than 45 cm;
- Acute illness, infection, or inflammation
- 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;
- A history of rest or exertional angina pectoris in the previous six (6) months;
- History of solid organ transplant
- 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;
- 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;
- 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;
- Patients who currently own or have owned another Zona Plus device and are, or have been, voluntarily performing the isometric handgrip activities.
- Subject plans for greater than 10% of body weight loss/gain (10% of body weight over a 6-month period) during the study
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Circuit Clinical Grave Gilbert
Bowling Green, Kentucky, 42101
Shivan Shah, 716-949-5521, sshah@circuitclinical.com
- Recruiting
Cedar Crosse Research Center
Chicago, Illinois, 60607
Dolores Rijos, 312-431-6780, drijos@cedarcrosse.com
- Recruiting
Community DPC
Cleveland, Tennessee, 37312
Mandy Jones, 423-380-7570, mandy@communitydpc.com
- Recruiting
Zenos Clinical Research
Dallas, Texas, 75230
Juan Zepeda, 469-949-4900, jzepeda@allianceclinicalnetwork.com
Mia Glasco, (469) 949-4900, mglasco@allianceclinicalnetwork.com
- Recruiting
Aavon Clinical Trials
Houston, Texas, 77074
Datiobong Udoeyop, 713-282-5600, udatiobong@aavonclinical.com
Zitiali Alanis, azitiali@aavonclinical.com
- Recruiting
Preferred Primary Care Physicians - Pittsburgh
Pittsburgh, Pennsylvania, 15243
Sara Ohm, 412-942-0023, sohm@ppcp.org
- Recruiting
Comprehensive Medical & Research
Plantation, Florida, 33317
Andrew Tillett, 561-714-3912, atillett@compmedical.net
Wilmer Santiesteban, 954-368-3529, wsantiesteban@compmedical.net
- Recruiting
Bayview Research Group
Valley Village, California, 91607
Karen Hung, 800-831-8308 ext. 107, khhung@bayviewresearch.com
- Recruiting
Preferred Primary Care Physicians - Washington
Washington, Pennsylvania, 15301
Sarah Dobrosky, 412-650-6155, sdobrosky@ppcp.org
Camille Lokuta, 724-222-7240, clokuta@ppcp.org
- Recruiting
Focus Clinical Research
West Hills, California, 91307
Sagrario Garcia, 818-253-8966 ext. 1310, sgarcia@allianceclinicalnetwork.com
Anitha Roobalingam, (818) 253-8966, aroobalingam@allianceclinicalnetwork.com
About this study
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.
Read the 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.
- Conditions
- Elevated Blood Pressure, Hypertension
- Being tested
- Zona Plus Device, Relaxing Music App
- Keywords
- Hypertension, Elevated Blood Pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zona Plus DeviceDevice
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.
Relaxing Music AppOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | Zona Plus Device Receives: Device: Zona Plus Device |
| Control | Active comparator | Relaxing music Receives: Other: Relaxing Music App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start27 Mar 2025
- Primary completionSep 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zona Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emergent Clinical Consulting, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843577
- Sponsor's protocol ID
- Zona-002
- Status last verified
- Jul 2026
- First submitted
- 20 Feb 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No