Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Nighttime blood pressure mystery: researchers track hidden heart risk

NCT ID NCT03598894

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at people with high blood pressure whose levels don't drop normally during sleep, a condition linked to worse health outcomes. Researchers will use wearable devices and smartphone apps to monitor blood pressure patterns over 24 hours. The goal is to understand how stable this 'non-dipping' pattern is and what biological rhythms might be involved.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors better understand and identify a risky form of high blood pressure that doesn't drop at night, potentially leading to more personalized treatment.
What could go wrong
This is an observational study, not a treatment trial. It aims to gather data, not test a cure or therapy, so direct patient benefits are not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2018

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Cohort 1 (case): Individuals with (Phase 1-) confirmed non-dipping phenotype 'NDHT'; Cohort 2 (control): matched healthy normotensives 'NT' (24h mean wake SBP \<120mmHg); Cohort 3 (control): matched dipping hypertensives 'DHT' (24h mean wake SBP \>145mmHg and a decline of \>10% between mean day time and night time systolic pressures);

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Phase 1: Inclusion Criteria (Stability of the non-dipping phenotype) 1. \>18 years of age, 2. Upper arm with intact skin, i.e. without areas of breached or injured skin visible, for ABP measurements, 3. 24h mean wake SBP \>145mmHg at baseline from 24hr-ABPM readings within the past 12 months, 4. Decline of \<10% between mean day time and night time systolic pressures quantified per 24hr-ABPM within the past 6 months, 5. Own a smartphone. Phase 1: Exclusion Criteria (Stability of the non-dipping phenotype) 1. Known history of severe psychiatric or cognitive conditions, for example mania, schizophrenia, or mental retardation. 2. Shift work, defined as recurring work between 22:00-05:00, 3. History of clinically significant obstructive sleep apnea; 4. Urine creatinine \> 1.5 mg/dl in men or \>1.3 mg/del in women, 5. Significant liver disease (\>3x upper limit of normal), 6. Diabetes mellitus, 7. Transmeridian travel across ≥2 time zones in the month prior to ABP sessions, 8. Planned transmeridian travel across more than ≥2 time zones during the planned study activities; 9. \> 2 drinks of alcohol per day; 10. Use of illicit drugs which affect blood pressure; 11. Use of pacemaker or implantable Cardioverter Defibrillator, (ICD); 12. Bilateral mastectomy; 13. Hypotension, defined as 90/60 mmHg assessed during the screening visit from ≥ 3 in-office measurements initiated after 10 minutes in seated upright position with 5 minute intervals between measurements; 14. History of Raynaud's phenomenon; 15. Known allergy against natural latex rubber (contained in ABP bladder and tubing); 16. Nursing or pregnant females. Phase 2: Inclusion Criteria (Deeply phenotyping non-dipping hypertensives) Inclusion Cohort 1 (case): non-dipping hypertensives 'NDHT' 1. \>18 years of age, 2. Upper arm with intact skin, i.e. without areas of breached or injured skin visible, for ABP measurements, 3. 24h mean wake SBP \>145mmHg from 24hr-ABPM readings confirmed per data base query within the past 12 months prior to enrollment into Phase 1 and across two subsequent 24hr-ABP sessions during Phase 1, 4. Decline of \<10% between mean day time and night time systolic pressures from 24hr-ABPM readings confirmed per data base query within the past 12 months prior to enrollment into Phase 1 and across two subsequent 24hr-ABP sessions during Phase 1, 5. Own a smartphone. Inclusion Cohort 2 (control): matched healthy normotensives 'NT' 1. \>18 years of age, 2. Upper arm with intact skin, i.e. without areas of breached or injured skin visible, for ABP measurements, 3. Healthy (as assessed by health history, physical exam and screening lab work), 4. 24h mean wake SBP \<130mmHg quantified per 24hr-ABPM, 5. Own a smartphone. 4.3.3 Inclusion Cohort 3 (control): matched dipping hypertensives 'DHT' 1\) \>18 years of age, 2) Upper arm with intact skin, i.e. without areas of breached or injured skin visible, for ABP measurements, 1. 24h mean wake SBP \>145mmHg from 24hr-ABPM readings, 2. Decline of \>10% between mean day time and night time systolic pressures from 24hr-ABPM readings, 3. Own a smartphone. Phase 2 - Exclusion Criteria Cohorts 1-3 1. History of severe psychiatric illness or cognitive conditions, for example ( mania, schizophrenia, or mental retardation; 2. Shift work, defined as recurring work between 22:00-05:00; 3. Clinically significant obstructive sleep apnea as assessed per WatchPAT device; 4. Urine creatinine \> 1.5 mg/dl in men or \>1.3 mg/del in women; 5. Significant liver disease (\>3x upper limit of normal); 6. Diabetes mellitus; 7. Past diagnosis of gastroesophageal reflux disease, 8. Transmeridian travel across ≥2 time zones in the two weeks before the 48hr deep phenotype sessions; 9. Frequent transmeridian flyer (≥2 flights per month) across more than ≥2 time zones during the 12 months of study activities; 10. Use of oral or intravenous antibiotics in the 6 months prior to enrollment; 11. Any contraindication listed below in the separate paragraph "Contraindications for the use of CorTemp® Disposable Temperature Sensors"; 12. Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening; 13. \> 2 drinks of alcohol per day; 14. Use of illicit drugs which affect blood pressure; 15. Nursing or pregnant (pregnancy will be repeatedly assessed at the beginning of each of the four inpatient visits, i.e. prior to the start of blood draws); 16. Use of pacemaker or implantable Cardioverter Defibrillator, (ICD) 17. Bilateral mastectomy; 18. Hypotension, defined as 90/60 mmHg assessed during the screening visit from ≥ 3 in-office measurements initiated after 10 minutes in seated upright position with 5 minute intervals between measurements; 19. History of Raynaud's phenomenon; 20. Known allergy against natural latex rubber (contained in ABP bladder and tubing); 21. Subjects taking medication with alpha-blockers; 22. History of clinically significant arrhythmias; 23. Subjects with a history of being particularly susceptible to vomiting or nausea; 24. BMI ≥ 30; 25. History of any type of GI Surgery.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hypertension are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.