CClinicalTrials.gg
Status unknownNCT03454516MHMUpdated Aug 9, 2018

Mobility Hypertension Management Study

An interventional study of telemonitoring in Hypertension, sponsored by International Society for Vascular Health. Status unknown at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-09.

Sponsored by International Society for Vascular Health · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension
  • Telemonitoring
  • Digital Health
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • No intervention
    Standard Care

    This group is the usual standard treatment group

  • Other
    Telemonitoring group

    This group will followed up with telemonitoring

    Other: telemonitoring

Interventions

  • Othertelemonitoring

    the follow-up of the patient will be performed with Telemonitoring

05

What researchers measure

Primary outcomes

  1. Systolic Blood Pressure (measured in clinic)

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

    Time frame: Primary objective after 3 month

Secondary outcomes

  1. Timing to reach the blood pressure target

    how long we need to reach the Blood pressure normalization

    Time frame: Evaluation performed at Month1 and Month 3

06

Study locations

1 of 1 sites recruiting
  • Roland Asmar
    Paris, 75016, France
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — the essential documents and the study results will be shared with all the investigators.

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03454516
Lead sponsor
International Society for Vascular Health
Responsible party
Sponsor
First posted
Mar 6, 2018
Start date
Jun 3, 2018
Primary completion
Jun 30, 2019 (estimated)
Completion
Dec 30, 2019 (estimated)
Last update
Aug 9, 2018

Study contacts

ROLAND ASMAR, MD
Contact
ra@cmcv.org
+33640142239
ROLAND ASMAR, MD
study chair · Foundation-Medical research Institutes

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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