Evaluation of Nocturnal Hypertension and Correlation With Target-Organ Damage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01533584
Recruitment Status : Unknown
Verified September 2012 by George S. Stergiou, University of Athens.
Recruitment status was:  Recruiting
First Posted : February 15, 2012
Last Update Posted : September 11, 2012
Information provided by (Responsible Party):
George S. Stergiou, University of Athens

Brief Summary:
The aim of this study is to evaluate nocturnal hypertension with 24-hour ambulatory blood pressure and home blood pressure (BP) measurements through a) comparison of mean BP and nocturnal dipping assessed with the two methods, b) correlation of those parameters with parameters of target-organ damage and c) comparison of the potential of the two methods to define non-dippers.

Condition or disease
Nocturnal Hypertension

Detailed Description:

It is well known that blood pressure (BP) exhibits diurnal variation. Nocturnal fall of BP normally exceeds 10%. Subjects with such fall of BP during sleep are classified as "dippers" and those with a nocturnal fall of BP less than 10% are classified as "non-dippers". Non-dippers are exposed to a greater cardiovascular risk. To date dipping status is defined with 24-hour ambulatory BP monitoring (ABPM). Many studies have shown that Home BP monitoring (HBPM) can be an alternative to daytime ambulatory BP monitoring and it exhibits similar correlation to markers of hypertension target-organ-damage (TOD). Nocturnal hypertension shows closer correlation with TOD, than daytime hypertension. In this study patients will be provided with a new-technology, reliable oscillometric device for HBPM, equipped with a modified algorithm, which allows scheduled automated BP measurements during sleep (Microlife WatchBP Home Nocturnal). Duplicate morning and evening BP measurements with one-minute interval will be performed by the patient sitting during seven working days. Afterwards a 24-hour ABPM will be performed, using Microlife WatchBP O3 oscillometric device, with a 20-minute interval between measurements. This order may be reversed according to the wish of the patient and devices' availability. Participants will visit site 3 times. Office blood pressure will be measured during two visits. Triplicate measurements with Microlife WatchBP Home Nocturnal will be performed at the sitting position.

TOD will be assessed with:

  • cardiac triplex (LVMI)
  • carotid triplex (ΙΜΤ)
  • pulse wave velocity.
  • Albumin/creatinine ratio measured in morning urine sample.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Nocturnal Hypertension With 24-hour Ambulatory or Home Blood Pressure Measurement: Correlation With Target-Organ Damage
Study Start Date : March 2012
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects referred for high Blood Pressure, untreated or, if treated for less than 2 weeks, 4 weeks after withdrwal of treatment.

Inclusion Criteria:

  • Mean 24-hour Systolic BP (SBP) >130 mmHg and/or Mean 24-hour Diastolic BP (DBP) >80 mmHg.
  • Patients physically and mentally capable of self-measuring BP at home.
  • Written informed consent.

Exclusion Criteria:

  • Sustained arrhythmia.
  • Pregnancy.
  • Symptomatic cardiovascular disease.
  • Any other serious illness (cardiac, renal, or malignancy).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01533584

Hypertension Clinic, 3rd Dept. of Medicine, Evaggelismos Hospital. Recruiting
Athens, Greece, 10676
Contact: Emmanuel A Andreadis, NHS Director    00302132045149   
Principal Investigator: Emmanuel A Andreadis, NHS Director         
Hypertension Center, Third Department of Medicine, University of Athens, Greece Recruiting
Athens, Greece, 11527
Contact: George S Stergiou, MD    +302107763117   
Principal Investigator: George S Stergiou, MD         
Sponsors and Collaborators
University of Athens

Responsible Party: George S. Stergiou, Associate Professor of Medicine and Hypertension, University of Athens Identifier: NCT01533584     History of Changes
Other Study ID Numbers: NOCTURNAL TOD
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases