Clinical trial NCT01533584: Evaluation of Nocturnal Hypertension and Correlation With Target-Organ Damage
Official title: Evaluation of Nocturnal Hypertension With 24-hour Ambulatory or Home Blood Pressure Measurement: Correlation With Target-Organ Damage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nocturnal Hypertension
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hypertension Clinic, 3rd Dept. of Medicine, Evaggelismos Hospital.
city: Athens
country: Greece
facility: Hypertension Center, Third Department of Medicine, University of Athens, Greece
Study officials:
References: