Hypertension, SystolicNCT04467879
A Pivotal Study To Evaluate The Effectiveness of Isometric Handgrip Therapy In Prehypertensive And Hypertensive Patients
A study testing Zona Plus Device in people with Hypertension, Systolic, run by Zona Health, Inc at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Systolic
- What is being tested?
- Zona Plus Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jun 2020to 14 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Carolinas Research Center LLC
Charlotte, North Carolina, 28215
Goldsboro Medical Center
Goldsboro, North Carolina, 27534
Sante Clinical Research
Kerrville, Texas, 78028
Sun Research Institute
San Antonio, Texas, 78215
Saint Louis Heart & Vascular, P.C.
St Louis, Missouri, 63044
About this study
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.
Read the 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
- Being tested
- Zona Plus Device, Control Device
- Keywords
- Diastolic Hypertension, HandGrip Therapy, Pre-Hypertension, Isometric Exercise, Vascular Hypertension
- Medical subject headings
- Isolated Systolic Hypertension, Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zona Plus DeviceDevice
Also called Zona Plus 3.0
Zona Plus 3.0 Individualized Isometric Handgrip Therapy Device
Control DeviceDevice
Zona Plus control sham device, with a nominal weaker grip
| Study group | Role | What they receive |
|---|---|---|
| Zona Plus - Active - "Normal Grip" | Experimental | Using the Zona Plus Device, the patient will perform a twelve-minute isometric handgrip therapy session at approximately the same time each day . After an initial handgrip strength assessment (the session calibration), a two-minute isometric routine is performed four times, two sessions per hand, with a one-minute non-grip, or rest session between each isometric routine. Receives: Device: Zona Plus Device |
| Control Device - Sham - "Weaker Grip" | Sham comparator | Using the Zona Sham Control Device the patient will perform a twelve-minute isometric handgrip therapy session at approximately the same time each day. After an initial handgrip strength assessment (the calibration), a two-minute isometric routine is performed four times, two sessions per hand, with a one-minute non-grip, or rest session between each isometric routine. Receives: Device: Control Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to Day 70 ±2 Days
Secondary outcomes (8)
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").
Measured: Change from Baseline to Day 70 ±2 Days
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.
Measured: Change from Baseline to Day 70 ± 2 Days
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.
Measured: Change from Baseline to Day 70 ± 2 Days
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.
Measured: Change from Baseline to Day 160 ± 4 Days
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.
Measured: Change from Baseline to Day 160 ± 4 Days
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
Measured: Change from Baseline to Day 160 ± 4 Days
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
Measured: Change from Baseline to Day 160 ± 4 Days
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.
Measured: Change from Baseline to Day 160 ± 4 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Jun 2020
- Primary completion13 Sep 2022
- Study completion14 Sep 2022
Why it stopped: New Protocol and Outcome Measures in Review
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Hypertension, SystolicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Prospective, double-blinded, randomized, sham-controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zona Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Research & Development Concierge Company
- Responsible party
- Sponsor
- Investigators
- Mark Young, Study chair, Zona Health, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467879
- Sponsor's protocol ID
- 001
- Status last verified
- Sep 2022
- First submitted
- 8 Jul 2020
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: If in the future Investigators want to access the data for secondary analysis they can submit a request from the Sponsor or R\&D Data Management Contact. Individual patient data will not be shared by the sponsor directly and will be aggregated, monitored, and de-identified (APD) via 1) final approved clinical study report 2) any manuscripts or summary results report via an email request to the central contact once database lock has occurred and reports are generated.
Publications
Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15.
PubMed 21160056Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.
PubMed 23851406Al-Khatib SM, Califf RM, Hasselblad V, Alexander JH, McCrory DC, Sugarman J. Medicine. Placebo-controls in short-term clinical trials of hypertension. Science. 2001 Jun 15;292(5524):2013-5. doi: 10.1126/science.1057783. No abstract available.
PubMed 11408643ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002 Dec 18;288(23):2981-97. doi: 10.1001/jama.288.23.2981.
PubMed 12479763Bakke EF, Hisdal J, Kroese AJ, Jorgensen JJ, Stranden E. Blood pressure response to isometric exercise in patients with peripheral atherosclerotic disease. Clin Physiol Funct Imaging. 2007 Mar;27(2):109-15. doi: 10.1111/j.1475-097X.2007.00720.x.
PubMed 17309531Balasubramanian V, Mann S, Millar-Craig MW, Raftery EB. Effect of labetalol in hypertension during exercise and postural changes. Br J Clin Pharmacol. 1979 Apr;8 Suppl 2:95S-100S. doi: 10.1111/j.1365-2125.1979.tb04761.x.
PubMed 26635176Black HR, Elliott WJ, Neaton JD, Grandits G, Grambsch P, Grimm RH Jr, Hansson L, Lacouciere Y, Muller J, Sleight P, Weber MA, White WB, Williams G, Wittes J, Zanchetti A, Fakouhi TD, Anders RJ. Baseline Characteristics and Early Blood Pressure Control in the CONVINCE Trial. Hypertension. 2001 Jan;37(1):12-18. doi: 10.1161/01.hyp.37.1.12.
PubMed 11208750Boutcher SH, Stocker D. Cardiovascular responses to light isometric and aerobic exercise in 21- and 59-year-old males. Eur J Appl Physiol Occup Physiol. 1999 Aug;80(3):220-6. doi: 10.1007/s004210050585.
PubMed 10453924Buck C, Donner AP. Isometric occupational exercise and the incidence of hypertension. J Occup Med. 1985 May;27(5):370-2. doi: 10.1097/00043764-198505000-00017.
PubMed 4009307Chrysant SG. Current evidence on the hemodynamic and blood pressure effects of isometric exercise in normotensive and hypertensive persons. J Clin Hypertens (Greenwich). 2010 Sep;12(9):721-6. doi: 10.1111/j.1751-7176.2010.00328.x.
PubMed 20883233Cushman WC, Ford CE, Cutler JA, Margolis KL, Davis BR, Grimm RH, Black HR, Hamilton BP, Holland J, Nwachuku C, Papademetriou V, Probstfield J, Wright JT Jr, Alderman MH, Weiss RJ, Piller L, Bettencourt J, Walsh SM; ALLHAT Collaborative Research Group. Success and predictors of blood pressure control in diverse North American settings: the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). J Clin Hypertens (Greenwich). 2002 Nov-Dec;4(6):393-404. doi: 10.1111/j.1524-6175.2002.02045.x.
PubMed 12461301Eguchi K, Yacoub M, Jhalani J, Gerin W, Schwartz JE, Pickering TG. Consistency of blood pressure differences between the left and right arms. Arch Intern Med. 2007 Feb 26;167(4):388-93. doi: 10.1001/archinte.167.4.388.
PubMed 17325301Fotherby MD, Panayiotou B, Potter JF. Age-related differences in simultaneous interarm blood pressure measurements. Postgrad Med J. 1993 Mar;69(809):194-6. doi: 10.1136/pgmj.69.809.194.
PubMed 8497433Gasowski J, Staessen JA, Celis H, Fagard RH, Thijs L, Birkenhager WH, Bulpitt CJ, Fletcher AE, Arabidze GG, de Leeuw P, Dollery CT, Duggan J, Kawecka-Jaszcz K, Leonetti G, Nachev C, Safar M, Rodico JL, Rosenfeld J, Seux ML, Tuomilehto J, Webster J, Yodfat Y. Systolic Hypertension in Europe (Syst-Eur) trial phase 2: objectives, protocol, and initial progress. Systolic Hypertension in Europe Investigators. J Hum Hypertens. 1999 Feb;13(2):135-45. doi: 10.1038/sj.jhh.1000769.
PubMed 10100063Grucza R, Kahn JF, Cybulski G, Niewiadomski W, Stupnicka E, Nazar K. Cardiovascular and sympatho-adrenal responses to static handgrip performed with one and two hands. Eur J Appl Physiol Occup Physiol. 1989;59(3):184-8. doi: 10.1007/BF02386185.
PubMed 2583160
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Study To Evaluate The Effectiveness of Isometric Handgrip Therapy In Prehypertensive And Hypertensive Patients
- ClinicalTrials.gov ID
- NCT04467879
- Acronym / sponsor ID
- 001
- Conditions
- Hypertension, Systolic
- Keywords
- Diastolic Hypertension, HandGrip Therapy, Pre-Hypertension, Isometric Exercise, Vascular Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New Protocol and Outcome Measures in Review
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Zona Health, IncIndustry (pharma, biotech, devices)
- Collaborators
- Research & Development Concierge Company
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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").
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, double-blinded, randomized, sham-controlled study
| Arm | Type | Receives |
|---|---|---|
| Zona Plus - Active - "Normal Grip" | Experimental | Device: Zona Plus DeviceUsing the Zona Plus Device, the patient will perform a twelve-minute isometric handgrip therapy session at approximately the same time each day . After an initial handgrip strength assessment (the session calibration), a two-minute isometric routine is performed four times, two sessions per hand, with a one-minute non-grip, or rest session between each isometric routine. |
| Control Device - Sham - "Weaker Grip" | Sham comparator | Device: Control DeviceUsing the Zona Sham Control Device the patient will perform a twelve-minute isometric handgrip therapy session at approximately the same time each day. After an initial handgrip strength assessment (the calibration), a two-minute isometric routine is performed four times, two sessions per hand, with a one-minute non-grip, or rest session between each isometric routine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zona Plus DeviceAlso: Zona Plus 3.0Zona Plus 3.0 Individualized Isometric Handgrip Therapy Device | Device | Zona Plus - Active - "Normal Grip" |
| Control DeviceZona Plus control sham device, with a nominal weaker grip | Device | Control Device - Sham - "Weaker Grip" |
Primary outcome
Change from Baseline in Systolic Blood Pressure to Day 70 ± 2 Days
Time frame: Change from Baseline 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.
8 secondary outcomes
Change from Baseline in Diastolic Blood Pressure to Day 70 ± 2 Days
Time frame: Change from Baseline to Day 70 ±2 Days
Percentage change from Baseline in Systolic Blood Pressure reduction at Day 70 ± 2 Days
Time frame: Change from Baseline to Day 70 ± 2 Days
Percentage change from Baseline in Diastolic Blood Pressure reduction at Day 70 ± 2 Days
Time frame: Change from Baseline to Day 70 ± 2 Days
Percentage change from Baseline in Systolic Blood Pressure reduction at Day 160 ± 4 Days
Time frame: Change from Baseline to Day 160 ± 4 Days
Percentage change in Diastolic Blood Pressure reduction at Day 160 ± 4 Days
Time frame: Change from Baseline to Day 160 ± 4 Days
Percentage change from Baseline in Systolic Blood Pressure reduction at Day 160 ± 4 Days
Time frame: Change from Baseline to Day 160 ± 4 Days
Percentage change in Diastolic Blood Pressure reduction at Day 160 ± 4 Days
Time frame: Change from Baseline to Day 160 ± 4 Days
Comparison of Heart Rate between Zona Plus nominal device and Placebo controlled device
Time frame: Change from Baseline to Day 160 ± 4 Days
Results and safety
The study was stopped early (reason given: New Protocol and Outcome Measures in Review). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Background: PubMed 21160056Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15.
- Background: PubMed 23851406Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.
- Background: PubMed 11408643Al-Khatib SM, Califf RM, Hasselblad V, Alexander JH, McCrory DC, Sugarman J. Medicine. Placebo-controls in short-term clinical trials of hypertension. Science. 2001 Jun 15;292(5524):2013-5. doi: 10.1126/science.1057783. No abstract available.
- Background: PubMed 12479763ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002 Dec 18;288(23):2981-97. doi: 10.1001/jama.288.23.2981.
- Background: PubMed 17309531Bakke EF, Hisdal J, Kroese AJ, Jorgensen JJ, Stranden E. Blood pressure response to isometric exercise in patients with peripheral atherosclerotic disease. Clin Physiol Funct Imaging. 2007 Mar;27(2):109-15. doi: 10.1111/j.1475-097X.2007.00720.x.
- Background: PubMed 26635176Balasubramanian V, Mann S, Millar-Craig MW, Raftery EB. Effect of labetalol in hypertension during exercise and postural changes. Br J Clin Pharmacol. 1979 Apr;8 Suppl 2:95S-100S. doi: 10.1111/j.1365-2125.1979.tb04761.x.
- Background: PubMed 11208750Black HR, Elliott WJ, Neaton JD, Grandits G, Grambsch P, Grimm RH Jr, Hansson L, Lacouciere Y, Muller J, Sleight P, Weber MA, White WB, Williams G, Wittes J, Zanchetti A, Fakouhi TD, Anders RJ. Baseline Characteristics and Early Blood Pressure Control in the CONVINCE Trial. Hypertension. 2001 Jan;37(1):12-18. doi: 10.1161/01.hyp.37.1.12.
- Background: PubMed 10453924Boutcher SH, Stocker D. Cardiovascular responses to light isometric and aerobic exercise in 21- and 59-year-old males. Eur J Appl Physiol Occup Physiol. 1999 Aug;80(3):220-6. doi: 10.1007/s004210050585.
- Background: PubMed 4009307Buck C, Donner AP. Isometric occupational exercise and the incidence of hypertension. J Occup Med. 1985 May;27(5):370-2. doi: 10.1097/00043764-198505000-00017.
- Background: PubMed 20883233Chrysant SG. Current evidence on the hemodynamic and blood pressure effects of isometric exercise in normotensive and hypertensive persons. J Clin Hypertens (Greenwich). 2010 Sep;12(9):721-6. doi: 10.1111/j.1751-7176.2010.00328.x.
- Background: PubMed 12461301Cushman WC, Ford CE, Cutler JA, Margolis KL, Davis BR, Grimm RH, Black HR, Hamilton BP, Holland J, Nwachuku C, Papademetriou V, Probstfield J, Wright JT Jr, Alderman MH, Weiss RJ, Piller L, Bettencourt J, Walsh SM; ALLHAT Collaborative Research Group. Success and predictors of blood pressure control in diverse North American settings: the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). J Clin Hypertens (Greenwich). 2002 Nov-Dec;4(6):393-404. doi: 10.1111/j.1524-6175.2002.02045.x.
- Background: PubMed 17325301Eguchi K, Yacoub M, Jhalani J, Gerin W, Schwartz JE, Pickering TG. Consistency of blood pressure differences between the left and right arms. Arch Intern Med. 2007 Feb 26;167(4):388-93. doi: 10.1001/archinte.167.4.388.
- Drug Labeling for Cardiovascular Outcome ClaimsLink provided by the sponsor.
- Principles for ClinicalEvaluation ofNew Antihypertensive Drugs.Link provided by the sponsor.
- The Seventh Report of the Joint National Committee on Prevention, Detection,Evaluation, and Treatment of High Blood PressureLink provided by the sponsor.
- Individual participant dataSharing planned: No. If in the future Investigators want to access the data for secondary analysis they can submit a request from the Sponsor or R\&D Data Management Contact. Individual patient data will not be shared by the sponsor directly and will be aggregated, monitored, and de-identified (APD) via 1) final approved clinical study report 2) any manuscripts or summary results report via an email request to the central contact once database lock has occurred and reports are generated.
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Hypertension, Hypertension, Systolic
Active, not recruitingPhase 2
Nicotinamide Riboside for Treating Elevated Systolic Blood Pressure and Arterial Stiffness in Middle-aged and Older Adults
Hypertension, Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Young study chair
Zona Health, Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zona Plus Device in people with Hypertension, Systolic, run by Zona Health, Inc at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: New Protocol and Outcome Measures in Review). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Systolic Blood Pressure to Day 70 ± 2 Days (time frame: Change from Baseline to Day 70 ±2 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04467879, which also lists 48 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.