Hypertension Chronobiome

NCT03598894 | Active Not Recruiting

• 1 other identifier: 828944
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Blood pressure [mmHg]

  Ambulatory blood pressure measurements (ABPM)

  24-48 hours

Secondary Outcomes (1)

• Dipping status [dimensionless ratio]

  24-48 hours

Study Arms (3)

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)

Other: Ambulatory blood pressure measurements

Control NT

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

Other: Ambulatory blood pressure measurements

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)

Other: Ambulatory blood pressure measurements

Interventions

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

Case NDHT; Control DHT; Control NT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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);

You may qualify if:

• \>18 years of age,
• Upper arm with intact skin, i.e. without areas of breached or injured skin visible, for ABP measurements,
• h 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 29215023 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Timed blood, saliva, swab, stool, urine samples

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Garret FitzGerald, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: July 16, 2018
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)