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NCT03049709 Clinical Trial

Non-invasive Validation of Non-invasive Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis

Diabetes Mellitus Clinical Trial

— MEASURE-cBP2  

Official title:
Non-invasive Automated Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis - Comparison With Non-Invasive Reference Values

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03049709
Other study ID # VA_noninvasive
Secondary ID
Status Completed
Phase N/A
First received February 6, 2017
Last updated December 24, 2017
Start date May 1, 2015
Est. completion date October 30, 2017

Study information
Verified date December 2017
Source Universitätsmedizin Mannheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There is growing evidence that central blood pressure is a better predictor of hypertensive end-organ damage and cardiovascular outcome than routine brachial readings.

The investigators aimed to evaluate the accuracy of a novel device for the non-invasive determination of central blood pressure based on automated oscillometric radial pulse wave analysis.

Recruitment information / eligibility
Status Completed
Enrollment 119
Est. completion date October 30, 2017
Est. primary completion date May 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- cardiovascular disease, diabetes mellitus or healthy control

Exclusion Criteria:

- inability to give informed consent

- hemodynamic instability

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Universitätsmedizin Mannheim Mannheim

Sponsors (1)
Lead Sponsor Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary agreement of systolic central blood pressure measurements 15 minutes
Primary agreement of diastolic central blood pressure measurements 15 minutes
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