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Tests treatment safety and results for Elevated Blood Pressure
Official title A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects
ClinicalTrials.gov ID: NCT06843577
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join 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)...
- Subject has baseline BP measurements collected and completes study device training during Baseline Assessment (Visit #1);
You likely can't join 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...
- 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...
- Patient has experienced hospitalization due to a hypertensive emergency, with impending or progressive target organ dysfunction (i.e., renal...
- A \>10 mmHg difference in seated cuff SBP between the right and left arms collected during the SEPV;
See the full eligibility criteria
Who can join
- 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 people present with SBP reading of ≥140mmHg they will receive heightened monitoring throughout the first month of the study
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Valley Village, California, United States
- Coral Gables, Florida, United States
- Chicago, Illinois, United States
- Bowling Green, Kentucky, United States
- Knoxville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valley Village, California, United States; Coral Gables, Florida, United States; Chicago, Illinois, United States; Bowling Green, Kentucky, United States; Knoxville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.