Hypertension Chronobiome

Recruiting

• Conditions: Hypertension
• Interventions: Other: Ambulatory blood pressure measurements

• Registration Number: NCT03598894
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-16
• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2026-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case NDHT	Ambulatory blood pressure measurements	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 DHT	Ambulatory blood pressure measurements	matched dipping hypertensives 'DHT' (24h mean wake SBP \>145mmHg and a decline of \>10% between mean day time and night time systolic pressures)
Control NT	Ambulatory blood pressure measurements	matched healthy normotensives 'NT' (24h mean wake SBP \<120mmHg)

Primary Outcome Measures

Name	Time	Method
Blood pressure [mmHg]	24-48 hours	Ambulatory blood pressure measurements (ABPM)

Secondary Outcome Measures

Name	Time	Method
Dipping status [dimensionless ratio]	24-48 hours	Ratio of ambulatory blood pressure measurements during sleep and waking hours

Trial Locations

Locations (1)

Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States