Trial Outcomes & Findings for Hybrid Blood Pressure Monitor Validation (NCT NCT01120990)

Results Overview

Mean Systolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

51 participants

Primary outcome timeframe

3 months

Results posted on

2012-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hybrid Blood Pressure Monitor Validation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=51 Participants All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Age Continuous	50.4 years STANDARD_DEVIATION 16.3 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Region of Enrollment Greece	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.

Mean Systolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.

Outcome measures

Outcome measures
Measure	All Patients n=51 Participants All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
Systolic Blood Pressure Measured by Tested Device.	144.11 mmHg Standard Deviation 27.72

PRIMARY outcome

Timeframe: 3 months

Population: According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.

Mean Systolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.

Outcome measures

Outcome measures
Measure	All Patients n=51 Participants All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
Systolic Blood Pressure Measured With Mercury Sphygmomanometer.	143.92 mmHg Standard Deviation 27.18

PRIMARY outcome

Timeframe: 3 months

Population: According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.

Mean Diastolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.

Outcome measures

Outcome measures
Measure	All Patients n=51 Participants All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
Diastolic Blood Pressure Measured by Tested Device.	90.72 mmHg Standard Deviation 20.02

PRIMARY outcome

Timeframe: 3 months

Population: According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.

Mean Diastolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.

Outcome measures

Outcome measures
Measure	All Patients n=51 Participants All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
Diastolic Blood Pressure Measured With Mercury Sphygmomanometer.	90.51 mmHg Standard Deviation 19.87

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, MD

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

Phone: +30 210 7763117

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place