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NCT04467879 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Zona Health.

Terminated
Registry status
NA
Development phase
146
Enrollment target

NCT04467879: Clinical Trial NA study, sponsored by Zona Health.

NCT04467879 is a NA study that was terminated before completion, run by Zona Health. The registered enrollment target is 146 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04467879, a NA study, was terminated before completion, sponsored by Zona Health.

TERMINATED
Registry status
NA
Development phase
146 participants
Enrollment target

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.

Primary Outcome

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.

Interventions

  • DEVICE Zona Plus Device
  • DEVICE Control Device

Trial Details

FieldValue
Enrollment Target 146 participants
Start Date 2020-06-01
Est. Completion 2022-09-14
Phase NA
Zona Health

2 total trials

Why NCT04467879 stopped before completion

NCT04467879 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 2 interventions - of which Zona Plus Device is the first listed.

NCT04467879 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04467879 about?

NCT04467879 is a clinical study titled "A Pivotal Study To Evaluate The Effectiveness of Isometric Handgrip Therapy In Prehypertensive And Hypertensive Patients". 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 day...

What is the current status of trial NCT04467879?

This trial is currently terminated. It is a NA study. The enrollment target is 146 participants. The study started on 2020-06-01. Estimated completion is 2022-09-14.

What interventions are being tested in trial NCT04467879?

The interventions under investigation include: Zona Plus Device (DEVICE), Control Device (DEVICE).

Who is sponsoring clinical trial NCT04467879?

This trial is sponsored by Zona Health, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04467879's enrollment target sits among peer trials

146 704th of 2000 higher than 1,296 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04467879, the US trial registry maintained by the National Library of Medicine. NCT04467879 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.