Isometric handgrip therapy with the Zona Plus device for high blood pressure

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

This trial tests whether using the Zona Plus handgrip device can lower blood pressure in adults with elevated blood pressure or hypertension who are not currently taking blood pressure medicines.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Zona Health, Inc (industry)
• Locations: 5 sites (Valley Village, California and 4 other locations)
• Trial ID: NCT06843577 on ClinicalTrials.gov

What this trial studies

This is a multi-center, randomized trial comparing a home-use Zona Plus isometric handgrip device to an auditory relaxation (music) app in adults with elevated blood pressure or hypertension who are not on antihypertensive medications. Participants randomized to the Zona Plus arm perform prescribed isometric handgrip sessions with device-recorded compliance; control participants listen to relaxing music and record compliance in a diary. Half of participants are further randomized to record blood pressure at home during the study, and those with baseline systolic BP 140–149 mmHg have three additional monitoring visits. Total participation lasts about 3–8 months and control-arm participants may cross over to the device after Visit 6.

Who should consider this trial

Good fit: Adults aged 22 or older with elevated blood pressure or hypertension, not taking antihypertensive medications for at least 30 days, who have sufficient vision, hearing, and hand strength and can attend clinic visits and follow study procedures.

Not a fit: People already taking blood pressure medications, those without adequate hand strength or dexterity, or those with more severe uncontrolled hypertension are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If effective, the device could provide a simple, non-drug way to lower blood pressure for some patients.

How similar studies have performed: Prior small randomized trials and meta-analyses of isometric handgrip training have shown modest reductions in systolic blood pressure, but large pivotal trials are limited.

Eligibility criteria

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

Where this trial is running

Valley Village, California and 4 other locations

• Bayview Research Group — Valley Village, California, United States (RECRUITING)
• AMR Miami — Coral Gables, Florida, United States (RECRUITING)
• Cedar Crosse Research Center — Chicago, Illinois, United States (RECRUITING)
• Circuit Clinical Grave Gilbert — Bowling Green, Kentucky, United States (RECRUITING)
• AMR Knoxville — Knoxville, Tennessee, United States (RECRUITING)

Study contacts

• Study coordinator: Martyna Stankute

Conditions: Elevated Blood Pressure, Hypertension