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

Launched by ZONA HEALTH, INC · Feb 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment for people with high blood pressure (also known as hypertension) who are not currently taking any medication for it. The study will compare the use of a special handgrip device called the Zona Plus to a relaxation therapy that uses sounds. The goal is to see which method is more effective in lowering blood pressure. Participants will also have the option to monitor their blood pressure at home during the study.

To join the trial, you need to be at least 22 years old and have been diagnosed with high blood pressure, with specific measurements taken during your first visit. You should not have taken any blood pressure medication for at least 30 days before starting the study. Also, you should be in good enough health to complete all study activities and understand the information provided. If you're eligible, you can expect to learn how to use the handgrip device, attend regular visits for monitoring, and help researchers understand more about managing high blood pressure without medication.

Gender

ALL

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