NCT03049709

Completed

Non-invasive Validation of Non-invasive Central Blood Pressu...

Universitätsmedizin Mannheim Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

VA_noninvasive

Study Type

observational

Actual enrollment (reported)

119

Locations

1 country

Sites

1

Timeline

Study Start

May 1, 2015

Actual (reported)

Primary Completion

May 31, 2017

Actual (reported)

Study Completion

October 30, 2017

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 119 participants
Study completion date: October 30, 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 1, 2015
Actual (reported)
First Submitted
February 6, 2017
Actual (reported)
First Posted
February 10, 2017
Actual (reported)
Primary Completion
May 31, 2017
Actual (reported)
Study Completion
October 30, 2017
Actual (reported)

Last Updated: December 27, 2017
Status Verified: December 2017
Last Update Submitted: December 24, 2017

Conditions

Arterial Hypertension Coronary Heart Disease Diabetes Mellitus Healthy Control

Keywords

central blood pressuremeasurementoscillometric radial pulse wave analysis

Outcome Measures

Primary Outcomes (2)

agreement of systolic central blood pressure measurements
15 minutes
agreement of diastolic central blood pressure measurements
15 minutes

Study Arms (2)

cardiovascular disease

patients with cardiovascular disease, invasive and non-invasive determination of central blood pressure

healthy controls

healthy controls, invasive and non-invasive determination of central blood pressure

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

in-patients and healthy controls (students, hospital staff)

You may qualify if:

cardiovascular disease, diabetes mellitus or healthy control

You may not qualify if:

Sponsors & Collaborators

Universitätsmedizin Mannheim
Otherlead

Study Sites (1)

Universitätsmedizin Mannheim

Mannheim, Germany

MeSH Terms

Conditions

HypertensionCoronary DiseaseDiabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

Jens J Kaden, MD
Universitätsmedizin Mannheim
PRINCIPAL INVESTIGATOR
Joachim Saur, MD
Universitätsmedizin Mannheim
PRINCIPAL INVESTIGATOR
Urs Benck, MD
Universitätsmedizin Mannheim
PRINCIPAL INVESTIGATOR

Enrollment

119 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: CROSS SECTIONAL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 10, 2017

Study Start

May 1, 2015

Actual (reported)

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inability to give informed consent
hemodynamic instability

Contact the study team to confirm eligibility.

Primary Completion

May 31, 2017

Actual (reported)

Study Completion

October 30, 2017

Actual (reported)

Last Updated

December 27, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT03049709
Data provider: ClinicalTrials.gov
Source updated: 2017-12-27
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:45 UTC

Locations

DE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

cardiovascular disease

healthy controls

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations