RecruitingNot ApplicableNCT06843577

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

Sponsor

Zona Health, Inc

Enrollment

160 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

Hypertension Elevated Blood Pressure

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 medications. Half of the study subjects will also be randomized to record blood pressure at home throughout the study.

Eligibility

Min Age: 22 Years

Inclusion Criteria9

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;
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

Exclusion Criteria17

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;
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

Interventions

DEVICEZona 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.

OTHERRelaxing 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).