RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-27

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06843577

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Martyna Stankute

CONTACT

(888) 804 7993

Martyna@emergentcro.com

Mark Young

CONTACT

(888) 804 7993

myoung@ryzeagency.com

Study Locations (Sites)

Bayview Research Group

Valley Village, California, 91607

United States

AMR Miami

Coral Gables, Florida, 33134

United States

Cedar Crosse Research Center

Chicago, Illinois, 60607

United States

Circuit Clinical Grave Gilbert

Bowling Green, Kentucky, 42101

United States

AMR Knoxville

Knoxville, Tennessee, 37909

United States

Collaborators and Investigators

Sponsor: Zona Health, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-27

Study Completion Date2027-05

Study Record Updates

Study Start Date2025-03-27

Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

Hypertension
Elevated Blood Pressure

Additional Relevant MeSH Terms

Elevated Blood Pressure
Hypertension