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Hypertension is a common condition with a concomitant burden of stroke, kidney disease and myocardial infarction. Its prevalence in developed societies is increasing as they age, and in less developed countries, as their populations assume aspects of the Western diet and lifestyle. Nocturnal non-dipping hypertension (NDHT) - the failure of blood pressure (BP) to dip at night - is estimated to complicate ~40% of hypertensives and is associated with poor outcomes. Randomized controlled trials have shown that a reduction of daytime systolic blood pressure by as little as 5mmHg on average (towards a target of 140mmHg) translates into a measurable clinical benefit. The peak nocturnal difference may be ~15-20mmHg systolic, illustrating the substantial potential for incremental benefit by adequate blood pressure control across the 24 hour cycle in this population. In this study, the investigators wish (i) to establish through repeated assessment, the stability of the non-dipping phenotype (Phase 1), and (ii) to deeply phenotype non-dippers by using parameters assessing day/night patterns, the chronobiome (Phase 2). To facilitate data collection over the course of the study, the investigators use wearable devices and mobile phone applications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case NDHT | 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) |
| |
| Control NT | matched healthy normotensives 'NT' (24h mean wake SBP <120mmHg) |
| |
| Control DHT | matched dipping hypertensives 'DHT' (24h mean wake SBP >145mmHg and a decline of >10% between mean day time and night time systolic pressures) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory blood pressure measurements | Other | Blood pressure will be assessed with ambulatory blood pressure measurements over the course of a day to discern day/night differences |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure [mmHg] | Ambulatory blood pressure measurements (ABPM) | 24-48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Dipping status [dimensionless ratio] | Ratio of ambulatory blood pressure measurements during sleep and waking hours | 24-48 hours |
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Phase 1: Inclusion Criteria (Stability of the non-dipping phenotype)
Phase 1: Exclusion Criteria (Stability of the non-dipping phenotype)
Phase 2: Inclusion Criteria (Deeply phenotyping non-dipping hypertensives)
Inclusion Cohort 1 (case): non-dipping hypertensives 'NDHT'
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,
Phase 2 - Exclusion Criteria Cohorts 1-3
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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);
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| Name | Affiliation | Role |
|---|---|---|
| Garret FitzGerald, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29215023 | Background | Skarke C, Lahens NF, Rhoades SD, Campbell A, Bittinger K, Bailey A, Hoffmann C, Olson RS, Chen L, Yang G, Price TS, Moore JH, Bushman FD, Greene CS, Grant GR, Weljie AM, FitzGerald GA. A Pilot Characterization of the Human Chronobiome. Sci Rep. 2017 Dec 7;7(1):17141. doi: 10.1038/s41598-017-17362-6. |
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to be determined
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Timed blood, saliva, swab, stool, urine samples