Non-dipping Hypertension and the Human Chronobiome

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• \>18 years of age,

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

• 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,

• 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,

• Own a smartphone.

• \>18 years of age,

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

• Healthy (as assessed by health history, physical exam and screening lab work),

• 24h mean wake SBP \<130mmHg quantified per 24hr-ABPM,

• 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,

• 24h mean wake SBP \>145mmHg from 24hr-ABPM readings,

• Decline of \>10% between mean day time and night time systolic pressures from 24hr-ABPM readings,

• Own a smartphone.

Locations
United States
Pennsylvania
Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
LaVenia Banas, CRN
banas@pennmedicine.upenn.edu
215-573-1862
Time Frame
Start Date: 2018-07-16
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 150
Treatments
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)
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov