Mobility Hypertension Management Study

Hypertension Clinical Trial

— MHM  

Official title:

Mobility Hypertension Management - Effect of Telemonitoring on Hypertension Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03454516
• Other study ID #: FMRIMHM2018
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: August 2018
• Source: International Society for Vascular Health
• Contact: ROLAND ASMAR, MD
• Phone: +33640142239
• Email: ra[@]cmcv.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• telemonitoring
the follow-up of the patient will be performed with Telemonitoring

Locations

Country	Name	City	State
France	Roland Asmar	Paris

Sponsors (1)

Lead Sponsor	Collaborator
International Society for Vascular Health

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Primary objective after 3 month
Secondary	Timing to reach the blood pressure target	how long we need to reach the Blood pressure normalization	Evaluation performed at Month1 and Month 3