Mobility Hypertension Management Study | NCT03454516

Studies
Mobility Hypertension Management Study

NCT03454516

Sponsor

International Society for Vascular Health

Status

Unknown status

Last Update Posted

Aug 9, 2018Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Hypertension

Interventions

telemonitoring

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 3, 2018Actual

Primary Completion Date

Jun 30, 2019Estimated

Completion Date

Dec 30, 2019Estimated

First Submitted Date

Feb 2, 2018

First Submission Date that Met QC Criteria

Mar 2, 2018

First Posted Date

Mar 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2018

Last Update Posted Date

Aug 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
telemonitoring	Other	the follow-up of the patient will be performed with Telemonitoring	Telemonitoring group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Timing to reach the blood pressure target	how long we need to reach the Blood pressure normalization	Evaluation performed at Month1 and Month 3

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ROLAND ASMAR, MD	Contact	+33640142239		ra@cmcv.org

Overall Officials

Name	Affiliation	Role
ROLAND ASMAR, MD	Foundation-Medical research Institutes	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Roland Asmar	Recruiting	Paris		75016	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

the essential documents and the study results will be shared with all the investigators.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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

URL

https://e-corelab.com/

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided