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

Suspected Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278732
• Other study ID #: EK D-4-10
• Status: Completed
• Phase: N/A
• First received: January 18, 2011
• Last updated: March 31, 2015
• Start date: January 2011
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Klinikum Wels-Grieskirchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Suspected Arterial Hypertension

Intervention

Other:
• no intervention performed
no intervention is performed

Locations

Country	Name	City	State
Austria	Cardiology Department, University of Graz	Graz
Austria	Cardiology Department, Klinikum Wels-Grieskirchen	Wels	Upper Austria
Germany	Cardiology Department, University of Lübeck	Lübeck
Greece	Sotiria Hospital 3rd Department of Internal Medicine	Athens
Italy	Department of Medical and Surgical Sciences, University of Brescia	Brescia
Italy	Clinica Medica, Hospitalo San Gerardo	Monza
Italy	Unit of Internal Medicine, Angiology and Arteriosclerosis, University of Perugia	Perugia
Spain	Hospital de Sagunto	Puerto de Sagunto
Switzerland	University of Basel	Basel
United Kingdom	Clinical pharmacology unit, University of Cambridge	Cambridge

Sponsors (4)

Lead Sponsor	Collaborator
Klinikum Wels-Grieskirchen	Austrian Society of Hypertension, European Regional Development Fund, I.E.M. (Stolberg, Germany)

Countries where clinical trial is conducted

Austria,  Germany,  Greece,  Italy,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular mass (m-mode echocardiography)		measured within 4 weeks from ABPM	No
Secondary	urine albumine / creatinine ratio		measured within 2 weeks from ABPM but before antihypertensive treatment is started	No