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

NCT06843577 | Recruiting FDA Device

• 1 other identifier: Zona-002
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Elevated Blood Pressure; Hypertension

Keywords

Hypertension; Elevated Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

  10 weeks

Study Arms (2)

Investigational

EXPERIMENTAL

Zona Plus Device

Control

ACTIVE COMPARATOR

Relaxing music

Other: Relaxing Music App

Interventions

Zona Plus Device 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.

Relaxing Music App OTHER

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).

Control

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zona Health, Inc: lead
• Emergent Clinical Consulting, LLC: collaborator

Study Sites (5)

Bayview Research Group

Valley Village, California, 91607, United States

RECRUITING

AMR Miami

Coral Gables, Florida, 33134, United States

RECRUITING

Cedar Crosse Research Center

Chicago, Illinois, 60607, United States

RECRUITING

Circuit Clinical Grave Gilbert

Bowling Green, Kentucky, 42101, United States

RECRUITING

AMR Knoxville

Knoxville, Tennessee, 37909, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Martyna Stankute

CONTACT

(888) 804 7993; Martyna@emergentcro.com

Mark Young

CONTACT

(888) 804 7993; myoung@ryzeagency.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 25, 2025
• Study Start: March 27, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)