Clinical trial NCT01278732: Central Blood Pressure Over 24 Hours (ABPM) and Left Ventricular Mass
Official title: Central Blood Pressure Over 24 Hours (ABPM) and Left Ventricular Mas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suspected Arterial Hypertension
Keywords: arterial hypertension
Lead sponsor: Klinikum Wels-Grieskirchen
Sponsor class: OTHER
Collaborators: name: Austrian Society of Hypertension
name: European Regional Development Fund
name: I.E.M. (Stolberg, Germany)
First posted: 2011-01-19
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

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.

Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular mass (m-mode echocardiography)
timeFrame: measured within 4 weeks from ABPM
Secondary outcomes:
measure: urine albumine / creatinine ratio
timeFrame: measured within 2 weeks from ABPM but before antihypertensive treatment is started
Other outcomes:
Locations:
city: Wels
country: Austria
facility: Cardiology Department, Klinikum Wels-Grieskirchen
state: Upper Austria
city: Graz
country: Austria
facility: Cardiology Department, University of Graz
city: Lübeck
country: Germany
facility: Cardiology Department, University of Lübeck
city: Athens
country: Greece
facility: Sotiria Hospital 3rd Department of Internal Medicine
city: Brescia
country: Italy
facility: Department of Medical and Surgical Sciences, University of Brescia
city: Monza
country: Italy
facility: Clinica Medica, Hospitalo San Gerardo
city: Perugia
country: Italy
facility: Unit of Internal Medicine, Angiology and Arteriosclerosis, University of Perugia
city: Puerto de Sagunto
country: Spain
facility: Hospital de Sagunto
city: Basel
country: Switzerland
facility: University of Basel
city: Cambridge
country: United Kingdom
facility: Clinical pharmacology unit, University of Cambridge
Study officials:
affiliation: Cardiology Department, Klinikum Wels-Grieskirchen, Austria
name: Thomas Weber, MD, associate professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.