Evaluation of Nocturnal Hypertension and Correlation With Target-Organ Damage

Nocturnal Hypertension Clinical Trial

Official title:

Evaluation of Nocturnal Hypertension With 24-hour Ambulatory or Home Blood Pressure Measurement: Correlation With Target-Organ Damage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01533584
• Other study ID #: NOCTURNAL TOD
• Status: Recruiting
• Phase: N/A
• First received: February 9, 2012
• Last updated: September 9, 2012
• Start date: March 2012
• Est. completion date: February 2014

Study information

• Verified date: September 2012
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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).

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hypertension
• Nocturnal Hypertension

Locations

Country	Name	City	State
Greece	Hypertension Center, Third Department of Medicine, University of Athens, Greece	Athens
Greece	Hypertension Clinic, 3rd Dept. of Medicine, Evaggelismos Hospital.	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece,