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Clinical Trials/NCT03454516
NCT03454516
Unknown
Not Applicable

Mobility Hypertension Management - Effect of Telemonitoring on Hypertension Management

International Society for Vascular Health1 site in 1 country400 target enrollmentJune 3, 2018
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
International Society for Vascular Health
Enrollment
400
Locations
1
Primary Endpoint
Systolic Blood Pressure (measured in clinic)
Last Updated
7 years ago

Overview

Brief Summary

The present prospective study aims to assess the efficacy of using the telehealth solution "Hypertension Monitor" in patients with hypertension by comparison to the standard care.

Detailed Description

Although, meta-analysis confirms that BP telemonitoring may represent a useful tool to improve hypertension management, the strength of the provided evidence is limited. Therefore, future well-designed, large-sample, prospective, controlled trials are mandatory to understand the benefit of BP telemonitoring. Recently, a specific telehealth solution for hypertension management has been developed in France (Hypertension Monitor - e-CoreLab®). The present prospective study aims to assess the efficacy of using the telehealth solution "Hypertension Monitor" in patients with hypertension by comparison to the standard care. The primary objective: To evaluate whether a home telehealth system can improve BP control and other risk factors in hypertensive individuals, as compared to the standard care.

Registry
clinicaltrials.gov
Start Date
June 3, 2018
End Date
December 30, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
International Society for Vascular Health
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Men or women
  • Age between 18 and 80 years
  • Patients with essential moderate Hypertension
  • untreated or not adequately treated (need for treatment changes)
  • Given written informed consent

Exclusion Criteria

  • Severe Hypertension (\>180/110 mmHg)
  • Difficulties to perform home blood pressure measurements
  • Patients with arm circumference \> 42 cm
  • Night shift workers
  • Body mass index \> 35 kg/m²
  • Atrial fibrillation and/or another arrhythmia
  • Pregnancy
  • Cardiovascular events (stroke, Myocardial infarction) in the last 6 months
  • Severe Sleep Apnea Syndrome

Outcomes

Primary Outcomes

Systolic Blood Pressure (measured in clinic)

Time Frame: Primary objective after 3 month

Systolic blood pressure will be measured in clinic according to the guidelines of the European Society of Hypertension (ESH).

Secondary Outcomes

  • Timing to reach the blood pressure target(Evaluation performed at Month1 and Month 3)

Study Sites (1)

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