Hypertension
Conditions
Brief summary
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.
Interventions
OTHERAmbulatory blood pressure measurements
Blood pressure will be assessed with ambulatory blood pressure measurements over the course of a day to discern day/night differences
Sponsors
University of Pennsylvania
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure [mmHg] | 24-48 hours | Ambulatory blood pressure measurements (ABPM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dipping status [dimensionless ratio] | 24-48 hours | Ratio of ambulatory blood pressure measurements during sleep and waking hours |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGarret FitzGerald, MD
University of Pennsylvania
Outcome results
None listed