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Home Versus Ambulatory Monitoring, Diurnal Blood Pressure Profile, Detection of Non-Dippers

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ClinicalTrials.gov Identifier: NCT01460732
Recruitment Status : Completed
First Posted : October 27, 2011
Results First Posted : June 12, 2012
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
George S. Stergiou, University of Athens

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Hypertension
Intervention Device: Blood Pressure Monitoring
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description All patients analyzed
Period Title: Overall Study
Started 81
Completed 81
Not Completed 0
Arm/Group Title All Patients
Hide Arm/Group Description All patients analyzed
Overall Number of Baseline Participants 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants
<=18 years
0
   0.0%
Between 18 and 65 years
62
  76.5%
>=65 years
19
  23.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants
58.1  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants
Female
38
  46.9%
Male
43
  53.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Greece Number Analyzed 81 participants
81
1.Primary Outcome
Title Awake Systolic Home Blood Pressure Measurement
Hide Description Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients analyzed
Overall Number of Participants Analyzed 81
Mean (Standard Deviation)
Unit of Measure: mmHg
131.5  (11.2)
2.Primary Outcome
Title Awake Diastolic Home Blood Pressure Measurement
Hide Description Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients analyzed
Overall Number of Participants Analyzed 81
Mean (Standard Deviation)
Unit of Measure: mmHg
79.9  (7.8)
3.Primary Outcome
Title Asleep Systolic Home Blood Pressure Measurement
Hide Description Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients analyzed
Overall Number of Participants Analyzed 81
Mean (Standard Deviation)
Unit of Measure: mmHg
114.8  (12.2)
4.Primary Outcome
Title Asleep Diastolic Home Blood Pressure Measurement
Hide Description Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients analyzed
Overall Number of Participants Analyzed 81
Mean (Standard Deviation)
Unit of Measure: mmHg
66.6  (7.9)
5.Primary Outcome
Title Awake Systolic Ambulatory Blood Pressure Measurement
Hide Description An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients analyzed
Overall Number of Participants Analyzed 81
Mean (Standard Deviation)
Unit of Measure: mmHg
130.0  (11.6)
6.Primary Outcome
Title Awake Diastolic Ambulatory Blood Pressure Measurement
Hide Description An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients analyzed
Overall Number of Participants Analyzed 81
Mean (Standard Deviation)
Unit of Measure: mmHg
81.0  (7.6)
7.Primary Outcome
Title Asleep Systolic Ambulatory Blood Pressure Measurement
Hide Description An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.
Time Frame 2weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients analyzed
Overall Number of Participants Analyzed 81
Mean (Standard Deviation)
Unit of Measure: mmHg
115.2  (10.7)
8.Primary Outcome
Title Asleep Diastolic Ambulatory Blood Pressure Measurement
Hide Description An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.
Time Frame 2weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients analyzed
Overall Number of Participants Analyzed 81
Mean (Standard Deviation)
Unit of Measure: mmHg
67.6  (6.9)
9.Secondary Outcome
Title Dippers Defined by ABPM and HBPM-Nocturnal
Hide Description As Dippers are defined the patients who displayed a nocturnal fall (Daytime-Nighttime BP/Daytime BP) in Systolic and/or Diastolic Blood Pressure by 10% or more, by each method. The rest of patients, with a nocturnal fall by less than 10% or even a rise of BP, are consequently defined as Non-Dippers.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had their Daytime and Nocturnal BP assessed by both methods.
Arm/Group Title ABPM HBPM-Nocturnal
Hide Arm/Group Description:
Dippers defined by ABPM.
Dippers defined by HBPM-Nocturnal.
Overall Number of Participants Analyzed 81 81
Measure Type: Number
Unit of Measure: percentage of patients
84 78
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description All patients analyzed
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   0/81 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.1%
All Patients
Affected / at Risk (%)
Total   0/81 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: George S. Stergiou
Organization: Hypertension Center, Third University Department of Medicine
Phone: 0030 210 7763117
EMail: gstergi@med.uoa.gr
Layout table for additonal information
Responsible Party: George S. Stergiou, University of Athens
ClinicalTrials.gov Identifier: NCT01460732    
Other Study ID Numbers: NOCTURNAL
First Submitted: October 25, 2011
First Posted: October 27, 2011
Results First Submitted: February 5, 2012
Results First Posted: June 12, 2012
Last Update Posted: July 10, 2012