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Clinical Trials/NCT03774147
NCT03774147
Unknown
Not Applicable

24-hour Ambulatory Blood Pressure Monitoring in Patients With Blood Pressure Above Thresholds in General Practice

University of Burgundy7 sites in 1 country1,067 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
University of Burgundy
Enrollment
1067
Locations
7
Primary Endpoint
Prevalence of 24-hour hypertension
Last Updated
7 years ago

Overview

Brief Summary

High blood pressure (HBP) is a major modifiable cardiovascular risk factor which prevalence is gradually increasing. Reducing blood pressure (BP) significantly decreases cardiovascular morbi-mortality. Nevertheless, BP control remains insufficient: only 51% of French patients using antihypertensive drugs achieve the BP control targets.

HBP is mostly diagnosed and managed in primary care. Nevertheless, office BP measurements are unreliable for BP control and poorer predict target organ damage. Ambulatory BP measurements are recommended for HBP diagnosis and follow-up. 24-hour ambulatory blood pressure monitoring (ABPM) is the most cost-effective strategy. Its superiority has been demonstrated for HBP diagnosis and cardiovascular prognosis.

In France, ABPM is poorly available and little studied in primary care. Therefore, the investigators conducted a regional prospective study to analyze the feasibility and benefits of ABPM among primary care hypertensive patients in daily practice.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
December 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Burgundy
Responsible Party
Principal Investigator
Principal Investigator

Dr Claire ZABAWA

University senior registrar

University of Burgundy

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Prevalence of 24-hour hypertension

Time Frame: at the time of ABPM, up to 30 days after the inclusion consultation

Proportion of patients with 24-hour high blood pressure in ABPM (24-hour systolic/diastolic BP\> 130/80 mmHg) among the patients with primary care office measured BP≥ 140/90 mmHg

Prevalence of nocturnal hypertension

Time Frame: at the time of ABPM, up to 30 days after the inclusion consultation

Proportion of patients with nocturnal high blood pressure in ABPM (nighttime systolic/diastolic BP\> 120/70 mmHg) among the patients with primary care office measured BP≥ 140/90 mmHg

Prevalence of diurnal hypertension

Time Frame: at the time of ABPM, up to 30 days after the inclusion consultation

Proportion of patients with diurnal high blood pressure in ABPM (daytime systolic/diastolic BP\> 135/85 mmHg) among the patients with primary care office measured BP≥ 140/90 mmHg

Prevalence of white-coat hypertension

Time Frame: at the time of ABPM, up to 30 days after the inclusion consultation

Proportion of patients with normotension in ABPM (daytime systolic/diastolic BP\< 135/85 mmHg AND/OR nighttime BP\< 120/70 mmHg AND/OR 24-hour BP\< 130/80 mmHg) among the patients with primary care office measured BP≥ 140/90 mmHg

Secondary Outcomes

  • Dipping(at the time of ABPM, up to 30 days after the inclusion consultation)
  • ABPM acceptability(at the time of ABPM, up to 30 days after the inclusion consultation)
  • ABPM side effects(at the time of ABPM, up to 30 days after the inclusion consultation)
  • Deprivation among hypertensive patients(at the time of ABPM, up to 30 days after the inclusion consultation)
  • ABPM validity(at the time of ABPM, up to 30 days after the inclusion consultation)

Study Sites (7)

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