A Pivotal Study To Evaluate The Effectiveness of Isometric Handgrip Therapy In Prehypertensive And Hypertensive Patients
NCT ID: NCT04467879
Last Updated: 2022-09-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
146 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-06-01
Study Completion Date
2022-09-14
Brief Summary
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This is a double-blind, sham-controlled clinical trial assessing the effectiveness of personalized isometric handgrip device therapy. Approximately 230 patients who present with a Systolic Blood Pressure reading of ≤ 149mmHg and who have not taken any antihypertensive medication for more than 30 days will be enrolled.
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Detailed Description
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This study is designed to examine the effectiveness of individualized isometric handgrip device therapy in prehypertension or hypertension patient subjects who are not at target BP and who are naive to anti-hypertensive medication for at least 30 days before screening. The investigational plan examines changes in blood pressure (BP) in up to 230 patient subjects who are randomized to either the "active" (i.e., the Zona Plus device proposed for marketing), or to a "sham" device (which is intentionally calibrated for a "weaker grip").
Conditions
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Hypertension, Systolic
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
SINGLE_GROUP
Prospective, double-blinded, randomized, sham-controlled study
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Double Blinded
Study Groups
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Zona Plus - Active - "Normal Grip"
Using the Zona Plus Device, the patient will perform a twelve-minute isometric handgrip therapy session at approximately the same time each day . After an initial handgrip strength assessment (the session calibration), a two-minute isometric routine is performed four times, two sessions per hand, with a one-minute non-grip, or rest session between each isometric routine.
Group Type
EXPERIMENTAL
Zona Plus Device
Intervention Type
DEVICE
Zona Plus 3.0 Individualized Isometric Handgrip Therapy Device
Control Device - Sham - "Weaker Grip"
Using the Zona Sham Control Device the patient will perform a twelve-minute isometric handgrip therapy session at approximately the same time each day. After an initial handgrip strength assessment (the calibration), a two-minute isometric routine is performed four times, two sessions per hand, with a one-minute non-grip, or rest session between each isometric routine.
Group Type
SHAM_COMPARATOR
Control Device
Intervention Type
DEVICE
Zona Plus control sham device, with a nominal weaker grip
Interventions
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Zona Plus Device
Zona Plus 3.0 Individualized Isometric Handgrip Therapy Device
Intervention Type
DEVICE
Control Device
Zona Plus control sham device, with a nominal weaker grip
Intervention Type
DEVICE
Other Intervention Names
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Zona Plus 3.0
Eligibility Criteria
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Inclusion Criteria
* Male or female of any ethnicity between 18 and 80 years of age
* Diagnosed with prehypertension or hypertension and verified during the Baseline visit
* Non-use of antihypertensive medication for ≥30 prior to screening
* Currently not taking any antihypertensive medications or decline to take any antihypertensive medications(e.g., diuretic, angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), \] beta-blocker (BB), renin inhibitor (RI), calcium channel blocker (CCB) or alpha-adrenergic agonist (clonidine))
* Sufficient vision with the patient able to see the screen prompts on the device, sufficient hearing with the patient able to hear the device audio prompts, sufficient hand strength (demonstrated by a maximum voluntary contraction equaling 35 units of force in both hands measured by the device)
* Baseline Blood Pressure measurements collected and study device training completed during the Baseline visit
* Non-use of medications and over the counter (OTC)supplement regimen related to hypertension throughout the study duration
* Only one patient per household can participate in the study, eliminating the potential of unblinding
* Able to comply with study procedures and agrees to complete all required study visits and associated activities
* Ability to give written informed consent in either English, Spanish or French •≤149 mmHg, Systolic Blood Pressure wherein patients who present with Systolic Blood Pressure readings ≥140 mmHg will receive heightened monitoring throughout the first month of the study
* Diagnosed with prehypertension or hypertension and verified during the Baseline visit
* Non-use of antihypertensive medication for ≥30 prior to screening
* Currently not taking any antihypertensive medications or decline to take any antihypertensive medications(e.g., diuretic, angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), \] beta-blocker (BB), renin inhibitor (RI), calcium channel blocker (CCB) or alpha-adrenergic agonist (clonidine))
* Sufficient vision with the patient able to see the screen prompts on the device, sufficient hearing with the patient able to hear the device audio prompts, sufficient hand strength (demonstrated by a maximum voluntary contraction equaling 35 units of force in both hands measured by the device)
* Baseline Blood Pressure measurements collected and study device training completed during the Baseline visit
* Non-use of medications and over the counter (OTC)supplement regimen related to hypertension throughout the study duration
* Only one patient per household can participate in the study, eliminating the potential of unblinding
* Able to comply with study procedures and agrees to complete all required study visits and associated activities
* Ability to give written informed consent in either English, Spanish or French •≤149 mmHg, Systolic Blood Pressure wherein patients who present with Systolic Blood Pressure readings ≥140 mmHg will receive heightened monitoring throughout the first month of the study
Exclusion Criteria
* Pregnant or not using adequate contraception
* Blood Pressure ≥150 mmHg (systolic) and/or \>90 mmHg (diastolic)
* History of heart failure
* 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
•\>10 mmHg difference in Systolic Blood Pressure between the right and left arms collected during screening
* Unstable Blood Pressure, 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 45cm
* Acute illness, infection, or inflammation
* Unstable cardiovascular disorder, such as MI, unstable angina, significant arrhythmia, stroke, or TIA within the last six (6)months, or other serious comorbidity impacting life expectancy to \< than a 1 year
* Rest or exertional angina pectoris in the previous six (6) months
* History of solid organ transplant
* 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
* Any 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
* Currently own or have owned another Zona Plus device and are,or have been,voluntarily performing the isometric handgrip activities.
* Blood Pressure ≥150 mmHg (systolic) and/or \>90 mmHg (diastolic)
* History of heart failure
* 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
•\>10 mmHg difference in Systolic Blood Pressure between the right and left arms collected during screening
* Unstable Blood Pressure, 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 45cm
* Acute illness, infection, or inflammation
* Unstable cardiovascular disorder, such as MI, unstable angina, significant arrhythmia, stroke, or TIA within the last six (6)months, or other serious comorbidity impacting life expectancy to \< than a 1 year
* Rest or exertional angina pectoris in the previous six (6) months
* History of solid organ transplant
* 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
* Any 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
* Currently own or have owned another Zona Plus device and are,or have been,voluntarily performing the isometric handgrip activities.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Research & Development Concierge Company
UNKNOWN
Sponsor Role
collaborator
Zona Health, Inc
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Mark Young
Role: STUDY_CHAIR
Zona Health, Inc
Locations
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Saint Louis Heart & Vascular, P.C.
St Louis, Missouri, United States
Site Status
Carolinas Research Center LLC
Charlotte, North Carolina, United States
Site Status
Goldsboro Medical Center
Goldsboro, North Carolina, United States
Site Status
Sante Clinical Research
Kerrville, Texas, United States
Site Status
Sun Research Institute
San Antonio, Texas, United States
Site Status
Countries
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United States
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Related Links
Access external resources that provide additional context or updates about the study.
http://www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-outcome-claims
Drug Labeling for Cardiovascular Outcome Claims
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073147.pdf
Principles for ClinicalEvaluation ofNew Antihypertensive Drugs.
http://www.nhlbi.nih.gov/files/docs/guidelines/jnc7full.pdf
The Seventh Report of the Joint National Committee on Prevention, Detection,Evaluation, and Treatment of High Blood Pressure
Other Identifiers
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001
Identifier Type: -
Identifier Source: org_study_id
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Handgrip Exercise Versus Walking on Blood Pressure
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NOT_YET_RECRUITING
NA
Isometric Handgrip Training Frequency and Blood Pressure in People With Hypertension
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RECRUITING
NA
Role of Wrist Based Blood Pressure Monitoring in Clinical Practice
NCT03862742
WITHDRAWN
Acute Effects of Handgrip on Blood Pressure in Hypertensive Adults
NCT04856553
COMPLETED
NA
Home Blood Pressure Study for Recent Stroke Survivors With High Blood Pressure *On Hold Due to Global Pandemic*
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UNKNOWN
NA
Assessment of Hand-grip in the Prevention of Postural Orthostatic Hypotension
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UNKNOWN
PHASE1
Effect of Isometric Handgrip Training on Ambulatory Blood Pressure in Patients With Hypertension
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RECRUITING
NA
Smartphone App-guided Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure
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RECRUITING
PHASE1
Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations
NCT06871462
RECRUITING
NA
Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension
NCT03945305
RECRUITING
NA
Technology-enabled Management Versus Usual Care for Blood Pressure
NCT05479461
RECRUITING
NA
Isometric and Dynamic Handgrip Training Effects on Hypertension
NCT06601738
COMPLETED
NA
The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension
NCT00594048
COMPLETED
NA
Feasibility and Effectiveness of a Ring-type Blood Pressure Measurement Device
NCT06084065
UNKNOWN
NA
Validation of Noninvasive Blood Pressure Device
NCT04676152
COMPLETED
NA
Effects of Telemonitoring and Telemedicine Service for Hypertensive Care
NCT01335984
COMPLETED
NA
The Dose Response Effect of Isometric Handgrip Training Frequency on Blood Pressure in Normotensive Individuals
NCT06329804
COMPLETED
NA
Remote Ischemic Conditioning for the Treatment of Resistant Hypertension
NCT05426707
UNKNOWN
NA