Trial Outcomes & Findings for Home Versus Ambulatory Monitoring, Diurnal Blood Pressure Profile, Detection of Non-Dippers (NCT NCT01460732)

NCT ID: NCT01460732

Last Updated: 2012-07-10

Results Overview

Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 81 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2012-07-10

Participant Flow

Participant milestones

Measure	All Patients All patients analyzed
Overall Study STARTED	81
Overall Study COMPLETED	81
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	All Patients n=81 Participants All patients analyzed
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	62 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants
Age Continuous	58.1 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Region of Enrollment Greece	81 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.

Outcome measures

Measure	All Patients n=81 Participants All patients analyzed	HBPM-Nocturnal Dippers defined by HBPM-Nocturnal.
Awake Systolic Home Blood Pressure Measurement	131.5 mmHg Standard Deviation 11.2	—

PRIMARY outcome

Timeframe: 2 weeks

Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.

Outcome measures

Measure	All Patients n=81 Participants All patients analyzed	HBPM-Nocturnal Dippers defined by HBPM-Nocturnal.
Awake Diastolic Home Blood Pressure Measurement	79.9 mmHg Standard Deviation 7.8	—

PRIMARY outcome

Timeframe: 2 weeks

Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.

Outcome measures

Measure	All Patients n=81 Participants All patients analyzed	HBPM-Nocturnal Dippers defined by HBPM-Nocturnal.
Asleep Systolic Home Blood Pressure Measurement	114.8 mmHg Standard Deviation 12.2	—

PRIMARY outcome

Timeframe: 2 weeks

Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.

Outcome measures

Measure	All Patients n=81 Participants All patients analyzed	HBPM-Nocturnal Dippers defined by HBPM-Nocturnal.
Asleep Diastolic Home Blood Pressure Measurement	66.6 mmHg Standard Deviation 7.9	—

PRIMARY outcome

Timeframe: 2 weeks

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.

Outcome measures

Measure	All Patients n=81 Participants All patients analyzed	HBPM-Nocturnal Dippers defined by HBPM-Nocturnal.
Awake Systolic Ambulatory Blood Pressure Measurement	130.0 mmHg Standard Deviation 11.6	—

PRIMARY outcome

Timeframe: 2 weeks

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.

Outcome measures

Measure	All Patients n=81 Participants All patients analyzed	HBPM-Nocturnal Dippers defined by HBPM-Nocturnal.
Awake Diastolic Ambulatory Blood Pressure Measurement	81.0 mmHg Standard Deviation 7.6	—

PRIMARY outcome

Timeframe: 2weeks

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.

Outcome measures

Measure	All Patients n=81 Participants All patients analyzed	HBPM-Nocturnal Dippers defined by HBPM-Nocturnal.
Asleep Systolic Ambulatory Blood Pressure Measurement	115.2 mmHg Standard Deviation 10.7	—

PRIMARY outcome

Timeframe: 2weeks

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.

Outcome measures

Measure	All Patients n=81 Participants All patients analyzed	HBPM-Nocturnal Dippers defined by HBPM-Nocturnal.
Asleep Diastolic Ambulatory Blood Pressure Measurement	67.6 mmHg Standard Deviation 6.9	—

SECONDARY outcome

Timeframe: 2 weeks

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

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.

Outcome measures

Measure	All Patients n=81 Participants All patients analyzed	HBPM-Nocturnal n=81 Participants Dippers defined by HBPM-Nocturnal.
Dippers Defined by ABPM and HBPM-Nocturnal	84 percentage of patients	78 percentage of patients

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

George S. Stergiou

Hypertension Center, Third University Department of Medicine

Phone: 0030 210 7763117

Email: gstergi@med.uoa.gr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place