Elevated Blood Pressure, Hypertension
Conditions
Keywords
Hypertension, Elevated Blood Pressure
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.
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.
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).
Sponsors
Emergent Clinical Consulting, LLC
Zona Health, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactMartyna Stankute
Backup ContactMark Young
Outcome results
None listed