Central Blood Pressure Over 24 Hours (ABPM) and Left Ventricular Mass

Completed

• Conditions: Suspected Arterial Hypertension
• Interventions: Other: no intervention performed

• Registration Number: NCT01278732
• Lead Sponsor: Klinikum Wels-Grieskirchen

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.

Detailed Description

It seems obvious that central blood pressures are pathophysiologically more relevant than peripheral blood pressures for the pathogenesis of cardiovascular disease: it is central systolic pressure (cSBP) against the heart ejects (afterload), and it is central pulse pressure (cPP) that distends the large elastic arteries. Indeed, cSBP and cPP have been associated more closely with left ventricular hypertrophy and carotid atherosclerosis as markers of hypertensive end-organ damage than brachial pressures in various populations. However, in these studies office blood pressure measurements have been used. As ABPM measurements per se show a closer association with hypertensive end-organ damage than office measurements, and as the investigators have recently developed and validated a novel algorithm (ARCSolver) to calculate central blood pressures from peripheral waveforms, the investigators speculate that cSBP measured during ABPM may be the best predictor of left ventricular mass.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

> 18 years of age,

• no intake of antihypertensive medications
• should have an indication for ABPM (suspected arterial hypertension)

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
untreated persons with suspected hypertension	no intervention performed	-

Primary Outcome Measures

Name	Time	Method
Left ventricular mass (m-mode echocardiography)	measured within 4 weeks from ABPM

Secondary Outcome Measures

Name	Time	Method
urine albumine / creatinine ratio	measured within 2 weeks from ABPM but before antihypertensive treatment is started

Trial Locations

Locations (10)

Hospital de Sagunto; 🇪🇸 Puerto de Sagunto, Spain

Clinical pharmacology unit, University of Cambridge; 🇬🇧 Cambridge, United Kingdom

Sotiria Hospital 3rd Department of Internal Medicine; 🇬🇷 Athens, Greece

University of Basel; 🇨🇭 Basel, Switzerland

Cardiology Department, University of Graz; 🇦🇹 Graz, Austria

Clinica Medica, Hospitalo San Gerardo; 🇮🇹 Monza, Italy

Cardiology Department, Klinikum Wels-Grieskirchen; 🇦🇹 Wels, Upper Austria, Austria

Department of Medical and Surgical Sciences, University of Brescia; 🇮🇹 Brescia, Italy

Cardiology Department, University of Lübeck; 🇩🇪 Lübeck, Germany

Unit of Internal Medicine, Angiology and Arteriosclerosis, University of Perugia; 🇮🇹 Perugia, Italy