Hypertension Trial, Recruiting NCT06843577 Sponsor: Zona Health, Inc Condition: Hypertension
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Hypertension Trial, Recruiting

NCT06843577
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 22 or older, of any gender
  • People who have been diagnosed with elevated blood pressure or high blood pressure, confirmed by a seated arm cuff measurement at the first visit
  • People who have not taken any blood pressure-lowering medications for at least 30 days before the screening visit
  • People who have adequate vision, hearing, and hand strength — specifically, hand strength must reach at least 35 units of force in both hands, as measured by a grip-strength device
  • People whose baseline blood pressure readings are collected and who complete training on the study device at the first visit
  • People who agree not to start or change any medications or over-the-counter supplements related to blood pressure during the treatment period
  • People who are able and willing to attend all required study visits and complete all study activities
  • People who can understand and sign a written consent form in the language provided
  • People whose seated systolic blood pressure (the top number) is between 130 and 149 mmHg — those at 140 mmHg or above will be monitored more closely during the first month

Who may not be able to join:

  • Women who could become pregnant and are not using an effective form of birth control, or who are currently pregnant, breastfeeding, or planning to become pregnant during the study
  • People whose blood pressure is 150 mmHg or higher (top number) and/or above 90 mmHg (bottom number)
  • People with a history of heart failure that is currently classified as severe (NYHA Class III or IV)
  • People who have a history of, or currently have, atrial fibrillation (an irregular heart rhythm condition)
  • People who have been hospitalised in the past 6 months due to a serious blood pressure emergency involving damage to organs such as the kidneys, heart, or brain
  • People whose blood pressure readings differ by more than 10 mmHg between the left and right arms at the screening visit
  • People whose blood pressure is considered unstable — meaning it varies by more than 5 mmHg between consecutive weekly readings taken to establish a starting measurement
  • People whose upper arm circumference is greater than 45 cm
  • People who currently have an acute illness, infection, or inflammation
  • People who have had a serious heart or blood vessel event — such as a heart attack, unstable chest pain, significant abnormal heart rhythm, stroke, or mini-stroke — within the past 6 months, or who have another serious health condition likely to affect life expectancy or study participation
  • People who have experienced chest pain at rest or during activity in the past 6 months
  • People who have had a solid organ transplant (such as a kidney, liver, or heart transplant)
  • People whose high blood pressure is caused by another underlying medical condition, such as a hormone disorder, steroid use, a tumour affecting the adrenal gland, a narrowing of the main heart artery, or untreated thyroid or parathyroid disease
  • People who are currently participating in another clinical trial that has not yet finished, or who plan to join another study within the next 6 months
  • People who, in the opinion of the study investigator, have any other condition or circumstance that could affect the quality of data collected or their ability to complete the study
  • People who currently own, or have previously owned, a Zona Plus device and have been using it for isometric handgrip exercises
  • People who plan to lose or gain more than 10% of their body weight over the course of the 6-month study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: (888) 804 7993

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Zona Health, Inc
Registry
ClinicalTrials.gov
Start date
27 March 2025
Est. completion
1 May 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Compare the change from baseline in mean seated cuff systolic blood pressure (SBP) after 10 weeks of treatment between patients randomized to the Zona Plus device and the patients in the control group.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov