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

NCT04467879 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2022-09-22

No results posted yet for this study

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.

Conditions

  • Hypertension, Systolic

Interventions

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

Sponsors & Collaborators

  • Research & Development Concierge Company

    collaborator UNKNOWN

  • Zona Health, Inc

    lead INDUSTRY

Principal Investigators

  • Mark Young · Zona Health, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2022-09-13
Completion
2022-09-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04467879 on ClinicalTrials.gov