A Pivotal Study To Evaluate The Effectiveness of Isometric Handgrip Therapy In Prehypertensive And Hypertensive Patients

Hypertension, Systolic Clinical Trial

Official title:

A Pivotal Study To Evaluate The Effectiveness of Isometric Handgrip Therapy In Prehypertensive And Hypertensive Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04467879
• Other study ID #: 001
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: September 14, 2022

Study information

• Verified date: September 2022
• Source: Zona Health, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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").

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 146
• Est. completion date: September 14, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Systolic

Intervention

Device:
• Zona Plus Device
Zona Plus 3.0 Individualized Isometric Handgrip Therapy Device
• Control Device
Zona Plus control sham device, with a nominal weaker grip

Locations

Country	Name	City	State
United States	Carolinas Research Center LLC	Charlotte	North Carolina
United States	Goldsboro Medical Center	Goldsboro	North Carolina
United States	Sante Clinical Research	Kerrville	Texas
United States	Saint Louis Heart & Vascular, P.C.	Saint Louis	Missouri
United States	Sun Research Institute	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Zona Health, Inc	Research & Development Concierge Company

Country where clinical trial is conducted

United States, 

References & Publications (48)

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* Note: There are 48 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Systolic Blood Pressure to Day 70 ± 2 Days	Comparative assessment in the change from Baseline in seated cuff Systolic Blood Pressure after ten(10) weeks of treatment between patients treated with the Zona Plus nominal device ("stronger grip") and patients treated with the Placebo control device ("weaker grip"). A reduction in Systolic Blood = 5 Preassure after 10 weeks of treatment is considered to be a better outcome.	Change from Baseline to Day 70 ±2 Days
Secondary	Change from Baseline in Diastolic Blood Pressure to Day 70 ± 2 Days	Comparative assessment of the change from Baseline in seated cuff Diastolic Blood Pressure after 10 weeks of treatment between patients treated with the Zona Plus nominal device ("stronger grip") and patients treated with the Placebo control device ("weaker grip").	Change from Baseline to Day 70 ±2 Days
Secondary	Percentage change from Baseline in Systolic Blood Pressure reduction at Day 70 ± 2 Days	Comparative assessment in the percentage of patients who achieve a clinically significant Systolic Blood Pressure reduction (defined as = 5 mmHg) at Day 70 ± 2 Days.	Change from Baseline to Day 70 ± 2 Days
Secondary	Percentage change from Baseline in Diastolic Blood Pressure reduction at Day 70 ± 2 Days	Comparative assessment in the percentage of patients who achieve a clinically significant Diastolic Blood Pressure reduction (defined as =3 mmHg) at Day 70 ± 2 Days.	Change from Baseline to Day 70 ± 2 Days
Secondary	Percentage change from Baseline in Systolic Blood Pressure reduction at Day 160 ± 4 Days	Comparative assessment in change from Baseline in the seated cuff Systolic Blood Pressure after 6 months Day 160 ± 4 of treatment between patients treated with the Zona Plus nominal device and patients treated with the Placebo control device.	Change from Baseline to Day 160 ± 4 Days
Secondary	Percentage change in Diastolic Blood Pressure reduction at Day 160 ± 4 Days	Comparative assessment in change from Baseline in the seated cuff Diastolic Blood Pressure after 6 months Day 160 ± 4 Days of treatment between patients treated with the Zona Plus nominal device and patients treated with the Placebo control device.	Change from Baseline to Day 160 ± 4 Days
Secondary	Percentage change from Baseline in Systolic Blood Pressure reduction at Day 160 ± 4 Days	Comparative assessment in the percentage of patients who achieve a clinically significant Systolic Blood Pressure reduction (defined as = 5 mmHg) at Day 160 ± 4 Days	Change from Baseline to Day 160 ± 4 Days
Secondary	Percentage change in Diastolic Blood Pressure reduction at Day 160 ± 4 Days	Comparative assessment in the percentage of patients who achieve a clinically significant Diastolic Blood Pressure reduction defined as =3 mmHg at Day 160 ± 4 Days	Change from Baseline to Day 160 ± 4 Days
Secondary	Comparison of Heart Rate between Zona Plus nominal device and Placebo controlled device	The Heart Rate (HR) will be recorded and compared between the Zona Plus nominal device and the Placebo control device treatment groups.	Change from Baseline to Day 160 ± 4 Days

External Links

•   Drug Labeling for Cardiovascular Outcome Claims
•   Principles for ClinicalEvaluation ofNew Antihypertensive Drugs.
•   The Seventh Report of the Joint National Committee on Prevention, Detection,Evaluation, and Treatment of High Blood Pressure