Is NCT06843577 recruiting in Knoxville, TN?

Yes, NCT06843577 is currently recruiting participants at its Knoxville, TN location. This elevated blood pressure clinical trial is actively enrolling qualified participants.

How do I join the elevated blood pressure clinical trial in Knoxville?

To join this clinical trial in Knoxville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Knoxville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Elevated Blood Pressure Clinical Trial in Knoxville, TN

About This Elevated Blood Pressure Study in Knoxville

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.

Sponsor: Zona Health, Inc

Who Can Participate

Inclusion Criteria

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 Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Knoxville?

Yes, this clinical trial (NCT06843577) has an active research site in Knoxville, TN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Elevated Blood Pressure Treatment Options in Knoxville, TN

If you're searching for elevated blood pressure treatment options in Knoxville, TN, this clinical trial (NCT06843577) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Knoxville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced elevated blood pressure specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all elevated blood pressure clinical trials near you to find additional studies recruiting in your area.

Elevated Blood Pressure Clinical Trial in Knoxville, TN

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