NCT01533584

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

1.9 years

First QC Date

February 9, 2012

Last Update Submit

September 9, 2012

Conditions

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects referred for high Blood Pressure, untreated or, if treated for less than 2 weeks, 4 weeks after withdrwal of treatment.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hypertension Clinic, 3rd Dept. of Medicine, Evaggelismos Hospital.

Athens, 10676, Greece

RECRUITING

Hypertension Center, Third Department of Medicine, University of Athens, Greece

Athens, 11527, Greece

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Hypertension

Study Record Dates

First Submitted

February 9, 2012

First Posted

February 15, 2012

Study Start

March 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations