Mobility Hypertension Management Study

NCT03454516 | Unknown DMC

• 1 other identifier: FMRIMHM2018
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Hypertension; Telemonitoring; Digital Health

Outcome Measures

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).

  Primary objective after 3 month

Secondary Outcomes (1)

• Timing to reach the blood pressure target

  Evaluation performed at Month1 and Month 3

Study Arms (2)

Standard Care

NO INTERVENTION

This group is the usual standard treatment group

Telemonitoring group

OTHER

This group will followed up with telemonitoring

Other: telemonitoring

Interventions

telemonitoring OTHER

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

Telemonitoring group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Society for Vascular Health: lead

Study Sites (1)

Roland Asmar

Paris, 75016, France

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• ROLAND ASMAR, MD

  Foundation-Medical research Institutes

  STUDY CHAIR

Central Study Contacts

ROLAND ASMAR, MD

CONTACT

+33640142239; ra@cmcv.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the Data analysis will be performed by an independent team with masking the patients groups
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two randomized parallel groups. one group with standard care and one group with telemonitoring of blood pressure and hypertension.

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: March 6, 2018
• Study Start: June 3, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 30, 2019
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Study documents: Q1 2018 Study Results: Q2 2019
• Access Criteria: the request will be reviewed by the scientific committee. Requestors will be required to sign an access agreement

Locations

FR (1)