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

• 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: University of Athens
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	All Patients
Arm/Group Description	All patients analyzed
Period Title: Overall Study
Started	81
Completed	81
Not Completed	0

Baseline Characteristics

Arm/Group Title		All Patients
Arm/Group Description		All patients analyzed
Overall Number of Baseline Participants		81
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

Outcome Measures

1. Primary Outcome

Title	Awake Systolic Home Blood Pressure Measurement
Description	Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
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
Description	Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
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
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

Outcome Measure Data

Analysis Population Description

All patients who had their Daytime and Nocturnal BP assessed by both methods.

Arm/Group Title	ABPM	HBPM-Nocturnal
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

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	All Patients
Arm/Group Description	All patients analyzed
All-Cause Mortality
	All Patients
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	All Patients
	Affected / at Risk (%)
Total	0/81 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: George S. Stergiou
• Organization: Hypertension Center, Third University Department of Medicine
• Phone: 0030 210 7763117
• EMail: gstergi@med.uoa.gr

• 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