Hypertension Chronobiome

Criteria the registry did not label

• Phase 1: Inclusion Criteria (Stability of the non-dipping phenotype)
• \>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 at baseline from 24hr-ABPM readings within the past 12 months,
• Decline of \<10% between mean day time and night time systolic pressures quantified per 24hr-ABPM within the past 6 months,
• Own a smartphone.
  • Phase 1: Exclusion Criteria (Stability of the non-dipping phenotype)
• Known history of severe psychiatric or cognitive conditions, for example mania, schizophrenia, or mental retardation.
• Shift work, defined as recurring work between 22:00-05:00,
• History of clinically significant obstructive sleep apnea;
• Urine creatinine \> 1.5 mg/dl in men or \>1.3 mg/del in women,
• Significant liver disease (\>3x upper limit of normal),
• Diabetes mellitus,
• Transmeridian travel across ≥2 time zones in the month prior to ABP sessions,
• Planned transmeridian travel across more than ≥2 time zones during the planned study activities;
• \> 2 drinks of alcohol per day;
• Use of illicit drugs which affect blood pressure;
• Use of pacemaker or implantable Cardioverter Defibrillator, (ICD);
• Bilateral mastectomy;
• 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;
• History of Raynaud's phenomenon;
• Known allergy against natural latex rubber (contained in ABP bladder and tubing);
• Nursing or pregnant females.
  • Phase 2: Inclusion Criteria (Deeply phenotyping non-dipping hypertensives)
  • Inclusion Cohort 1 (case): non-dipping hypertensives 'NDHT'
• \>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.
  • Inclusion Cohort 2 (control): matched healthy normotensives 'NT'
• \>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.
  • Phase 2 - Exclusion Criteria Cohorts 1-3
• History of severe psychiatric illness or cognitive conditions, for example ( mania, schizophrenia, or mental retardation;
• Shift work, defined as recurring work between 22:00-05:00;
• Clinically significant obstructive sleep apnea as assessed per WatchPAT device;
• Urine creatinine \> 1.5 mg/dl in men or \>1.3 mg/del in women;
• Significant liver disease (\>3x upper limit of normal);
• Diabetes mellitus;
• Past diagnosis of gastroesophageal reflux disease,
• Transmeridian travel across ≥2 time zones in the two weeks before the 48hr deep phenotype sessions;
• Frequent transmeridian flyer (≥2 flights per month) across more than ≥2 time zones during the 12 months of study activities;
• Use of oral or intravenous antibiotics in the 6 months prior to enrollment;
• Any contraindication listed below in the separate paragraph "Contraindications for the use of CorTemp® Disposable Temperature Sensors";
• 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;
• \> 2 drinks of alcohol per day;
• Use of illicit drugs which affect blood pressure;
• 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);
• Use of pacemaker or implantable Cardioverter Defibrillator, (ICD)
• Bilateral mastectomy;
• 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;
• History of Raynaud's phenomenon;
• Known allergy against natural latex rubber (contained in ABP bladder and tubing);
• Subjects taking medication with alpha-blockers;
• History of clinically significant arrhythmias;
• Subjects with a history of being particularly susceptible to vomiting or nausea;
• BMI ≥ 30;
• History of any type of GI Surgery.