Trial Outcomes & Findings for International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring (NCT NCT02577835)

NCT ID: NCT02577835

Last Updated: 2024-12-16

Results Overview

24-hour average value for arterial stiffness was assessed through estimation of the time traveled by the pulse wave from the central arterial tree (aorta) to the peripheral arteries (brachial artery) and measured in meters per sec. The faster the wave travels through the arterial tree, the stiffer the artery is.

• Recruitment status: COMPLETED
• Target enrollment: 2000 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2024-12-16

Participant Flow

Participant milestones

Measure	Hypertensive Patients No intervention. Patients will be sumbitted to standard tests required for hypertension management, including ambulatory blood pressure monitoring, and pharmacologically treated according to recommendations of international guidelines. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambualtory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations. Ambulatory blood pressure monitoring: Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.
Overall Study STARTED	1342
Overall Study COMPLETED	1200
Overall Study NOT COMPLETED	142

Reasons for withdrawal

Measure

Hypertensive Patients No intervention. Patients will be sumbitted to standard tests required for hypertension management, including ambulatory blood pressure monitoring, and pharmacologically treated according to recommendations of international guidelines. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambualtory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations. Ambulatory blood pressure monitoring: Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.

Overall Study Ambulatory blood pressure recordings were not valid for the analysis

142

Baseline Characteristics

International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring

Baseline characteristics by cohort

Measure	Hypertensive Patients n=1200 Participants No intervention. Patients will be sumbitted to standard tests required for hypertension management, including ambulatory blood pressure monitoring, and pharmacologically treated according to recommendations of international guidelines. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambualtory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations. Ambulatory blood pressure monitoring: Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	905 Participants n=5 Participants
Age, Categorical >=65 years	295 Participants n=5 Participants
Age, Continuous	52.6 years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	536 Participants n=5 Participants
Sex: Female, Male Male	664 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	59 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	84 Participants n=5 Participants
Race (NIH/OMB) White	1057 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Argentina	82 participants n=5 Participants
Region of Enrollment Romania	53 participants n=5 Participants
Region of Enrollment Italy	321 participants n=5 Participants
Region of Enrollment Mexico	71 participants n=5 Participants
Region of Enrollment Australia	108 participants n=5 Participants
Region of Enrollment Kazakhstan	22 participants n=5 Participants
Region of Enrollment Portugal	144 participants n=5 Participants
Region of Enrollment Russia	399 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

24-hour average value for arterial stiffness was assessed through estimation of the time traveled by the pulse wave from the central arterial tree (aorta) to the peripheral arteries (brachial artery) and measured in meters per sec. The faster the wave travels through the arterial tree, the stiffer the artery is.

Outcome measures

Measure

Hypertensive Patients n=1200 Participants No intervention. Patients will be sumbitted to standard tests required for hypertension management, including ambulatory blood pressure monitoring, and pharmacologically treated according to recommendations of international guidelines. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambualtory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations. Ambulatory blood pressure monitoring: Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.

24-hour Pulse Wave Velocity (PWV)

10.6 m/s Standard Deviation 2.6

PRIMARY outcome

Timeframe: 2 years

24-hour average value for waves reflection expressed as a percentage. The augmentation index is a measure of wave reflection and arterial stiffness and is commonly measured as the ratio of the central pulse pressure and the reflected pulse pressure which augments the central blood pressure. When arteries are stiff, a reflected wave is formed where arteries split. This reflected wave moves back at the heart and increases the pressure at which the heart has to pump. The higher the index the stiffer the artery is.

Outcome measures

Measure

Hypertensive Patients n=1200 Participants No intervention. Patients will be sumbitted to standard tests required for hypertension management, including ambulatory blood pressure monitoring, and pharmacologically treated according to recommendations of international guidelines. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambualtory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations. Ambulatory blood pressure monitoring: Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.

24-hour Augmentation Index (AI)

18.0 percent Standard Deviation 18.6

PRIMARY outcome

Timeframe: 2 years

24-hour average central aortic pressure expressed in mmHg, as the estimated blood pressure at the level of the thoracic aorta

Outcome measures

Measure

Hypertensive Patients n=1200 Participants No intervention. Patients will be sumbitted to standard tests required for hypertension management, including ambulatory blood pressure monitoring, and pharmacologically treated according to recommendations of international guidelines. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambualtory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations. Ambulatory blood pressure monitoring: Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.

24-hour Central Blood Pressure

117.2 mmHg Standard Deviation 12.8

SECONDARY outcome

Timeframe: 2 years

Average 24-hour brachial systolic blood pressure (mmHg), namely the systolic blood pressure measured at the level of the brachial artery (upper arm).

Outcome measures

Measure

Hypertensive Patients n=1200 Participants No intervention. Patients will be sumbitted to standard tests required for hypertension management, including ambulatory blood pressure monitoring, and pharmacologically treated according to recommendations of international guidelines. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambualtory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations. Ambulatory blood pressure monitoring: Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.

24-hour Systolic Blood Pressure

128.1 mmHg Standard Deviation 14.3

SECONDARY outcome

Timeframe: 2 years

Average 24-hour brachial diastolic blood pressure (mmHg), namely the diastolic blood pressure measured at the level of the brachial artery (upper arm).

Outcome measures

Measure

Hypertensive Patients n=1200 Participants No intervention. Patients will be sumbitted to standard tests required for hypertension management, including ambulatory blood pressure monitoring, and pharmacologically treated according to recommendations of international guidelines. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambualtory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations. Ambulatory blood pressure monitoring: Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.

24-hour Diastolic Blood Pressure

79.4 mmHg Standard Deviation 9.6

SECONDARY outcome

Timeframe: 2 years

Left ventricular mass indexed by body surface area (g/m^2) is used to identify left ventricular hypertrophy in case it is increased above a certain threshold (see protocol).

Outcome measures

Measure

Hypertensive Patients n=1200 Participants No intervention. Patients will be sumbitted to standard tests required for hypertension management, including ambulatory blood pressure monitoring, and pharmacologically treated according to recommendations of international guidelines. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambualtory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations. Ambulatory blood pressure monitoring: Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.

Cardiac Damage (Left Ventricular Hypertrophy at Echocardiogram or ECG)

109.6 g/m^2 Standard Deviation 21.3

SECONDARY outcome

Timeframe: 2 years

Intima media tickness (mm) measured by carotid ultrasonography is used to identify wall thickening or atherosclerotic plaque, when it is above a certain threshold (see protocol).

Outcome measures

Measure

Hypertensive Patients n=1200 Participants No intervention. Patients will be sumbitted to standard tests required for hypertension management, including ambulatory blood pressure monitoring, and pharmacologically treated according to recommendations of international guidelines. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambualtory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations. Ambulatory blood pressure monitoring: Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.

Vascular Damage (Carotid Plaque at Ultrasonography)

1.2 mm Standard Deviation 0.5

SECONDARY outcome

Timeframe: 2 years

Urine proteine (mg/24h). The increase above a certain threshold of urine protein is a sign of renal damage (see protocol).

Outcome measures

Measure

Hypertensive Patients n=1200 Participants No intervention. Patients will be sumbitted to standard tests required for hypertension management, including ambulatory blood pressure monitoring, and pharmacologically treated according to recommendations of international guidelines. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambualtory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations. Ambulatory blood pressure monitoring: Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.

Renal Damage (Urine Protein)

105.4 mg/24h Standard Deviation 129.2

SECONDARY outcome

Timeframe: 4 years

Population: The subgroup of patients followed for the occurrence of major cardiovascular event and all-cause death

The outcome variables consisted of a combination of nonfatal (i.e., not causing death) and fatal events (i.e., causing death) and all-cause death. The outcome variables included transient ischemic attack (TIA) or stroke (ischemic or hemorrhagic), myocardial infarction, angina pectoris or coronary revascularization, heart failure, peripheral vascular disease, and renal failure.

All outcomes were recorded by the Investigator on the date of the first occurrence or on the last study visit.

Outcome measures

Measure

Hypertensive Patients n=591 Participants No intervention. Patients will be sumbitted to standard tests required for hypertension management, including ambulatory blood pressure monitoring, and pharmacologically treated according to recommendations of international guidelines. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambualtory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations. Ambulatory blood pressure monitoring: Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.

Combination of Non-fatal and Fatal CV and Renal Events or All-cause Death

104 Participants

Adverse Events

Hypertensive Patients

Serious events: 80 serious events

Other events: 0 other events

Deaths: 24 deaths

Serious adverse events

Measure	Hypertensive Patients n=591 participants at risk No intervention. Patients will be sumbitted to standard tests required for hypertension management, including ambulatory blood pressure monitoring, and pharmacologically treated according to recommendations of international guidelines. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambualtory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations. Ambulatory blood pressure monitoring: Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.
Vascular disorders Transient Ischemic Attack (TIA) or stroke (ischemic or hemorragic)	4.1% 24/591 • Number of events 42 • 4.2 years The following adverse events were collected: 1. All-Cause Mortality: the occurrence of death due to any cause (cardiovascular and non cardiovascular) 2. Serious Adverse Events: included nonfatal events (hospitalization) due to transient ischemic attack or stroke (ischemic or hemorragic), myocardial infarction, angina pectoris, or coronary revascularization, heart failure, peripheral vascular disease, renal failure. 3. Other Adverse Events: not applicable for this study
Cardiac disorders Myocardial infarction, angina pectoris, or coronary revascularization	3.2% 19/591 • Number of events 19 • 4.2 years The following adverse events were collected: 1. All-Cause Mortality: the occurrence of death due to any cause (cardiovascular and non cardiovascular) 2. Serious Adverse Events: included nonfatal events (hospitalization) due to transient ischemic attack or stroke (ischemic or hemorragic), myocardial infarction, angina pectoris, or coronary revascularization, heart failure, peripheral vascular disease, renal failure. 3. Other Adverse Events: not applicable for this study
Cardiac disorders Heart failure	2.9% 17/591 • Number of events 17 • 4.2 years The following adverse events were collected: 1. All-Cause Mortality: the occurrence of death due to any cause (cardiovascular and non cardiovascular) 2. Serious Adverse Events: included nonfatal events (hospitalization) due to transient ischemic attack or stroke (ischemic or hemorragic), myocardial infarction, angina pectoris, or coronary revascularization, heart failure, peripheral vascular disease, renal failure. 3. Other Adverse Events: not applicable for this study
Vascular disorders Peripheral vascular disease	1.2% 7/591 • Number of events 7 • 4.2 years The following adverse events were collected: 1. All-Cause Mortality: the occurrence of death due to any cause (cardiovascular and non cardiovascular) 2. Serious Adverse Events: included nonfatal events (hospitalization) due to transient ischemic attack or stroke (ischemic or hemorragic), myocardial infarction, angina pectoris, or coronary revascularization, heart failure, peripheral vascular disease, renal failure. 3. Other Adverse Events: not applicable for this study
Renal and urinary disorders Renal failure	2.2% 13/591 • Number of events 13 • 4.2 years The following adverse events were collected: 1. All-Cause Mortality: the occurrence of death due to any cause (cardiovascular and non cardiovascular) 2. Serious Adverse Events: included nonfatal events (hospitalization) due to transient ischemic attack or stroke (ischemic or hemorragic), myocardial infarction, angina pectoris, or coronary revascularization, heart failure, peripheral vascular disease, renal failure. 3. Other Adverse Events: not applicable for this study

Other adverse events

Adverse event data not reported

Additional Information

Stefano Omboni

Italian Institute of Telemedicine

Phone: 00390331984176

Email: stefano.omboni@iitelemed.org

Results disclosure agreements

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