NCT01278732

Brief Summary

The investigators aim to investigate whether central systolic blood pressure, as measured during regular 24 hour ambulatory blood pressure monitoring (ABPM), is a better predictor of left ventricular mass than peripheral systolic blood pressure during ABPM.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
7 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 3, 2015

Status Verified

March 1, 2015

Enrollment Period

4.2 years

First QC Date

January 18, 2011

Last Update Submit

March 31, 2015

Conditions

Suspected Arterial Hypertension

Keywords

arterial hypertension

Outcome Measures

Primary Outcomes (1)

  • Left ventricular mass (m-mode echocardiography)

    measured within 4 weeks from ABPM

Secondary Outcomes (1)

  • urine albumine / creatinine ratio

    measured within 2 weeks from ABPM but before antihypertensive treatment is started

Study Arms (1)

untreated persons with suspected hypertension

Other: no intervention performed

Interventions

no intervention performedOTHER

no intervention is performed

untreated persons with suspected hypertension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • \> 18 years of age,
  • no intake of antihypertensive medications
  • should have an indication for ABPM (suspected arterial hypertension)

You may not qualify if:

  • no written informed consent
  • left ventricular hypertrophy due to other reasons than hypertension (hypertrophic cardiomyopathy, infiltrative cardiomyopathy, valvular heart disease, congenital heart disease)
  • inability to provide adequate echocardiographic readings
  • segmental contraction abnormalities of the left ventricle
  • contraindications for ABPM (lymphedema both arms)
  • other rhythm than stable sinus rhythm
  • unstable clinical condition, including recent severe infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Cardiology Department, Klinikum Wels-Grieskirchen

Wels, Upper Austria, 4600, Austria

Location

Cardiology Department, University of Graz

Graz, Austria

Location

Cardiology Department, University of Lübeck

Lübeck, Germany

Location

Sotiria Hospital 3rd Department of Internal Medicine

Athens, Greece

Location

Department of Medical and Surgical Sciences, University of Brescia

Brescia, Italy

Location

Clinica Medica, Hospitalo San Gerardo

Monza, Italy

Location

Unit of Internal Medicine, Angiology and Arteriosclerosis, University of Perugia

Perugia, Italy

Location

Hospital de Sagunto

Port de Sagunt, E - 46520, Spain

Location

University of Basel

Basel, Switzerland

Location

Clinical pharmacology unit, University of Cambridge

Cambridge, United Kingdom

Location

Related Publications (1)

  • Weber T, Wassertheurer S, Schmidt-Trucksass A, Rodilla E, Ablasser C, Jankowski P, Lorenza Muiesan M, Giannattasio C, Mang C, Wilkinson I, Kellermair J, Hametner B, Pascual JM, Zweiker R, Czarnecka D, Paini A, Salvetti M, Maloberti A, McEniery C. Relationship Between 24-Hour Ambulatory Central Systolic Blood Pressure and Left Ventricular Mass: A Prospective Multicenter Study. Hypertension. 2017 Dec;70(6):1157-1164. doi: 10.1161/HYPERTENSIONAHA.117.09917. Epub 2017 Oct 23.

    PMID: 29061725DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Thomas Weber, MD, associate professor

    Cardiology Department, Klinikum Wels-Grieskirchen, Austria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. Thomas Weber

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 19, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 3, 2015

Record last verified: 2015-03

Locations

GR(1)IT(3)AU(2)ES(1)CH(1)GB(1)DE(1)