NCT04467879

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Zona Health, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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").

Conditions

• Hypertension, Systolic

Interventions

Type	Name	Description
DEVICE	Zona Plus Device	Zona Plus 3.0 Individualized Isometric Handgrip Therapy Device
DEVICE	Control Device	Zona Plus control sham device, with a nominal weaker grip

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-09-13
• Completion: 2022-09-14
• First posted: 2020-07-13
• Last updated: 2022-09-22

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study