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Clinical Trials/NCT04607239
NCT04607239
Unknown
Not Applicable

HOme telemonitoRing of Arterial hypertensiOn With antihypertenSive Treatment Titration: a Randomized COntrolled prosPEctive Trial

Les Laboratoires des Médicaments Stériles1 site in 1 country460 target enrollmentJuly 4, 2020
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ConditionsHealth Services AdministrationTelemedicineHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health Services Administration
Sponsor
Les Laboratoires des Médicaments Stériles
Enrollment
460
Locations
1
Primary Endpoint
Mean of 24h systolic blood pressure (SBP)
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Rater blinded, multi-center, prospective, randomized controlled study comparing mean 24 hour systolic blood pressure of eligible hypertensive patients in the TELEMONITORIN group versus the USUAL CARE group, at 6 months after inclusion.

Registry
clinicaltrials.gov
Start Date
July 4, 2020
End Date
July 30, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Included are patients with:
  • •age ≥ 35 years old
  • •newly diagnosed hypertention
  • •uncontrolled hypertention

Exclusion Criteria

  • •Excluded are patients with:
  • •orthostatic hypotension
  • •chronic renal failure (serum creatinine \> 200 micromol / L)
  • •acute coronary syndrome
  • •coronary revascularization or stroke within the past 3 months
  • •known secondary causes of hypertension
  • •pregnancy
  • •New York Heart Association Class III or IV heart failure or left ventricular ejection fraction \< 30%
  • •dementia or another cause that prevents the application of remote monitoring

Outcomes

Primary Outcomes

Mean of 24h systolic blood pressure (SBP)

Time Frame: 0 - 180 days

The change from baseline of mean 24-hour systolic blood pressure (SBP) at 6 months of follow-up

Secondary Outcomes

  • percentage of Dipping(0-180 days)
  • frequency of cardiovascular complications(180 days)
  • Mean of the Short Form survey (SF-12) scores(0-180 days)
  • Mean of 24h diastolic blood pressure (DBP)(0-180 days)
  • percentage of blood pressure load(0-180 days)

Study Sites (1)

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