150 Participants Needed

Hypertension Chronobiome

LB
Overseen ByLaVenia Banas, CRN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

GF

Garret FitzGerald, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

Inclusion Criteria

Phase 1: Inclusion Criteria (Stability of the non-dipping phenotype)
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
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Stability Assessment

Establish the stability of the non-dipping phenotype through repeated assessment

4 weeks
Multiple assessments using wearable devices

Phase 2: Deep Phenotyping

Deeply phenotype non-dippers by assessing day/night patterns and the chronobiome

4 weeks
Continuous monitoring with wearable devices and mobile applications

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Ambulatory blood pressure measurements
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Control NTExperimental Treatment1 Intervention
matched healthy normotensives 'NT' (24h mean wake SBP \<120mmHg)
Group II: Control DHTExperimental Treatment1 Intervention
matched dipping hypertensives 'DHT' (24h mean wake SBP \>145mmHg and a decline of \>10% between mean day time and night time systolic pressures)
Group III: Case NDHTExperimental Treatment1 Intervention
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)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+
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