Ambulatory Blood Pressure Measurements for High Blood Pressure

Overseen By LaVenia Banas, CRN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must not be taking: Illicit drugs, Alpha-blockers

Disqualifiers: Severe psychiatric illness, Diabetes, Obstructive sleep apnea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand high blood pressure at night, known as nocturnal non-dipping hypertension (NDHT). Researchers seek to assess the stability of this condition and explore its patterns using wearable devices and smartphone apps for ambulatory blood pressure measurements. They focus on individuals whose blood pressure does not significantly drop at night compared to the day. Individuals with high blood pressure and a night-time dip of less than 10% who own a smartphone might qualify for this study. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research and potentially improve future treatments for NDHT.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does exclude participants using illicit drugs that affect blood pressure and those taking medications with alpha-blockers.

What prior data suggests that ambulatory blood pressure measurements are safe for monitoring hypertension?

Research has shown that checking blood pressure with a portable monitor is safe and reliable. Studies have found this method to be very accurate—up to 91.6%—when taking a certain number of readings during the day and night. This makes it generally easy to use and free of major risks for participants.

Using a portable blood pressure monitor is common for tracking blood pressure over 24 hours. Since it doesn't involve needles or surgery, it is safe for most people. However, readings might be less accurate during exercise or if someone has an irregular heartbeat. Overall, this method is safe and provides useful information about blood pressure changes throughout the day and night. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how ambulatory blood pressure measurements can provide insights into hypertension patterns over a 24-hour period. Unlike traditional blood pressure monitoring that offers snapshots at single points in time, this approach captures continuous data, allowing for a better understanding of non-dipping hypertension, where blood pressure does not decrease at night as it should. This method could lead to more personalized treatment strategies by identifying specific blood pressure patterns, potentially improving outcomes for those with hypertension.

What evidence suggests that ambulatory blood pressure measurements are effective for managing nocturnal non-dipping hypertension?

Research has shown that monitoring blood pressure throughout the day and night can reveal important patterns. For example, some individuals experience "nondipping" hypertension, where blood pressure does not decrease at night, potentially leading to more serious heart and kidney problems. In this trial, participants will be grouped into different arms based on their blood pressure patterns: healthy non-dipping hypertensives (NDHT), matched healthy normotensives (NT), and matched dipping hypertensives (DHT). Studies have found that ambulatory blood pressure monitoring, which measures blood pressure over 24 hours, is the most effective method for identifying these patterns. This approach can also predict future heart issues more accurately than regular office checks. Understanding these patterns allows for more effective management of blood pressure throughout the day and night. ^{1 2 6 7 8}

Who Is on the Research Team?

Garret FitzGerald, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

Inclusion Criteria

Phase 1: Inclusion Criteria (Stability of the non-dipping phenotype)

Upper arm with intact skin, i.e. without areas of breached or injured skin visible, for ABP measurements

24h mean wake SBP >145mmHg at baseline from 24hr-ABPM readings within the past 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Stability Assessment

Establish the stability of the non-dipping phenotype through repeated assessment

4 weeks

Multiple assessments using wearable devices

Phase 2: Deep Phenotyping

Deeply phenotype non-dippers by assessing day/night patterns and the chronobiome

4 weeks

Continuous monitoring with wearable devices and mobile applications

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ambulatory blood pressure measurements

How Is the Trial Designed?

Group I: Control NT Experimental Treatment 1 Intervention

matched healthy normotensives 'NT' (24h mean wake SBP \<120mmHg)

Group II: Control DHT Experimental Treatment 1 Intervention

matched dipping hypertensives 'DHT' (24h mean wake SBP \>145mmHg and a decline of \>10% between mean day time and night time systolic pressures)

Group III: Case NDHT Experimental Treatment 1 Intervention

Healthy non-dipping hypertensives 'NDHT' (24h mean wake SBP \>145mmHg at baseline and a decline of \<10% between mean day time and night time systolic pressures)

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11442022/

Identifying an acceptable number of ambulatory blood ... The highest accuracy for dipping status was 91.6 ± 13.4% using 20 daytime and 10 nighttime measures, while the lowest was (83.4 ± 15.1%) using 8 daytime and 4 ...

2. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.122.19996

Pathophysiology of the Nondipping Blood Pressure Pattern Patients with nondipper and riser BP pattern have more severe target organ damage and poorer renal and cardiovascular outcomes than dippers.

3. journals.plos.org journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000267

Classification of blood pressure during sleep impacts ... The identification of nocturnal nondipping hypertension has been shown to be a risk factor for future cardiovascular disease, however, requires ...

4. nature.com nature.com/articles/s41440-022-01137-2

Status of ambulatory blood pressure monitoring and home ... However, data have demonstrated that BP may substantially differ when measured in the office than when measured outside the office setting.

5. clinicalhypertension.biomedcentral.com clinicalhypertension.biomedcentral.com/articles/10.1186/s40885-021-00180-4

Clinical risk factors and predictive score for the non-dipper ... Ambulatory blood pressure monitoring (ABPM) is the best method for the detection of non-dippers and is a better predictor of hypertension- ...

6. stacks.cdc.gov stacks.cdc.gov/view/cdc/208463

Identifying an Acceptable Number of Ambulatory Blood ... Identifying an acceptable number of ambulatory blood pressure measurements for accuracy of average blood pressure and nocturnal dipping status

7. ahajournals.org ahajournals.org/doi/10.1161/hypertensionaha.113.02148

Ambulatory Blood Pressure Measurement | Hypertension ABPM is particularly appropriate for the initial evaluation because it provides standardized and unbiased information within 24 hours and without need of ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3920799/

Ambulatory Blood Pressure Monitoring in the Diagnosis ... Ambulatory BP readings may not be accurate when taken during exercise, movement, or driving or when cardiac rhythm is irregular (e.g., atrial fibrillation).