Hypertension
Conditions
Keywords
Hypertension, Arterial Stiffness, Ambulatory blood pressure
Brief summary
This Registry is an investigator-initiated, international, multicenter, observational, prospective study aiming at: i) evaluating non-invasive 24-h ambulatory blood pressure and arterial stiffness estimates (through 24-h pulse wave analysis) in hypertensive subjects; ii) assessing the changes in estimates following treatment; iii) weighing the impact of 24-h pulse wave analysis on target organ damage and cardiovascular prognosis; iv) assessing the relationship between arterial stiffness, blood pressure absolute level and variability, and prognosis. Approximately 2000 subjects, referred to 20 hypertension clinics for routine diagnostic evaluation and follow-up of hypertension, will be recruited. Data collection will include ambulatory blood pressure monitoring, performed with a device allowing simultaneous non-invasive assessment of blood pressure and arterial stiffness, and clinical data (including cardiovascular outcomes). A web-based telemedicine platform will be used for data collection. Subjects will visit the centers at 6-12 month intervals. First follow-up results are expected to be available in the next 2-years. The results of the Registry will help defining the normalcy thresholds for current and future indices derived from 24-h pulse wave velocity, according to outcome data. They will also provide supporting evidence for the inclusion of such evaluation in recommendations on hypertension management.
Detailed description
The VASOTENS Registry is an international, multicenter, observational, prospective project Actually, it is a large database of ambulatory blood pressure recordings obtained with a non-invasive device, able to determine central blood pressure and various indices of arterial stiffness (mainly pulse wave velocity and augmentation index) over the 24-hours, based on a clinically validated technology of pulse wave analysis of oscillometric blood pressure measurements, integrated in an ambulatory blood pressure monitor. Specifically, this project aims at creating an international network of centers performing ambulatory blood pressure monitoring and arterial stiffness monitoring, in order to evaluate the impact of such estimates on the clinical outcome of hypertensive patients. The results of the data collected at baseline and during regular follow-up of hypertensive patients (up to 2 years) will help to provide evidence on the clinical usefulness of such technologies for the screening and follow-up of the hypertensive patients. 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 ambulatory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations. Data collection is ensured by a dedicated web-based telemedicine platform, including an electronic case report form (e-CRF). The e-CRF allows collection of patient's clinical data, such as family history, anthropometric data, habits, past and current diseases, therapies, office blood pressure, and laboratory tests, including evaluation of target organ damage. The project does not involve any type of intervention related to the study and the physicians can manage the patients included in the Registry according to the requirements of clinical practice and current guidelines. However, as recommended by current guidelines, each patient has to be followed-up with visits occurring at regular intervals (ideally every 6 months, and not less than once a year). The physicians is also free to use the ambulatory blood pressure data in the clinical management of the patients. At least 30 Hypertension centers are planned to be involved in the project, each one providing at least 100 patients, which have to be followed-up over time. Centers will be selected in different countries, initially in Europe, starting from Italy and Russia. Mandatory criteria of a center to be included in the study are the availability in the facility of a BPLab ambulatory blood pressure monitor, the potential for providing and properly following-up the number of patients required by the protocol, the availability of Internet connection, regular access to the web and human resources to upload ambulatory blood pressure and clinical data.
Interventions
Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.
Sponsors
BPLab
Italian Institute of Telemedicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects referred to routine diagnostic evaluation for hypertension or established hypertensive subject * ABPM performed for clinical reasons with a BPLab device * Valid ambualtory blood pressure recordings (interval between measurements not \>30 minutes, at least 70% of expected number of readings, at least 20 valid readings during the day-time and 7 during the night-time) * Availability of individual measurements for ambulatory blood pressure monitoring * Availability of basic demographic and clinical information * Availability of a signed informed consent form
Exclusion criteria
* Age \<18 years * Atrial fibrillation, frequent ectopic beats, second or third degree atrioventricular blocks, or other conditions which might make difficult or unreliable the automatic blood pressure measurement with the oscillometric technique * Upper arm circumference \<22 cm * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour Pulse Wave Velocity (PWV) | 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. |
| 24-hour Augmentation Index (AI) | 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. |
| 24-hour Central Blood Pressure | 2 years | 24-hour average central aortic pressure expressed in mmHg, as the estimated blood pressure at the level of the thoracic aorta |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vascular Damage (Carotid Plaque at Ultrasonography) | 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). |
| 24-hour Systolic Blood Pressure | 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). |
| Combination of Non-fatal and Fatal CV and Renal Events or All-cause Death | 4 years | 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. |
| Renal Damage (Urine Protein) | 2 years | Urine proteine (mg/24h). The increase above a certain threshold of urine protein is a sign of renal damage (see protocol). |
| 24-hour Diastolic Blood Pressure | 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). |
| Cardiac Damage (Left Ventricular Hypertrophy at Echocardiogram or ECG) | 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). |
Countries
Argentina, Armenia, Australia, Italy, Kazakhstan, Mexico, Portugal, Romania, Russia, Ukraine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,200 |
| Total | 1,200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ambulatory blood pressure recordings were not valid for the analysis | 142 |
Baseline characteristics
| Characteristic | Hypertensive Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 295 Participants |
| Age, Categorical Between 18 and 65 years | 905 Participants |
| Age, Continuous | 52.6 years STANDARD_DEVIATION 15.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 59 Participants |
| Race (NIH/OMB) Black or African American | 84 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1057 Participants |
| Region of Enrollment Argentina | 82 participants |
| Region of Enrollment Australia | 108 participants |
| Region of Enrollment Italy | 321 participants |
| Region of Enrollment Kazakhstan | 22 participants |
| Region of Enrollment Mexico | 71 participants |
| Region of Enrollment Portugal | 144 participants |
| Region of Enrollment Romania | 53 participants |
| Region of Enrollment Russia | 399 participants |
| Sex: Female, Male Female | 536 Participants |
| Sex: Female, Male Male | 664 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 24 / 591 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 80 / 591 |
Outcome results
Primary
24-hour Augmentation Index (AI)
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.
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypertensive Patients | 24-hour Augmentation Index (AI) | 18.0 percent | Standard Deviation 18.6 |
Primary
24-hour Central Blood Pressure
24-hour average central aortic pressure expressed in mmHg, as the estimated blood pressure at the level of the thoracic aorta
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypertensive Patients | 24-hour Central Blood Pressure | 117.2 mmHg | Standard Deviation 12.8 |
Primary
24-hour Pulse Wave Velocity (PWV)
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.
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypertensive Patients | 24-hour Pulse Wave Velocity (PWV) | 10.6 m/s | Standard Deviation 2.6 |
Secondary
24-hour Diastolic Blood Pressure
Average 24-hour brachial diastolic blood pressure (mmHg), namely the diastolic blood pressure measured at the level of the brachial artery (upper arm).
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypertensive Patients | 24-hour Diastolic Blood Pressure | 79.4 mmHg | Standard Deviation 9.6 |
Secondary
24-hour Systolic Blood Pressure
Average 24-hour brachial systolic blood pressure (mmHg), namely the systolic blood pressure measured at the level of the brachial artery (upper arm).
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypertensive Patients | 24-hour Systolic Blood Pressure | 128.1 mmHg | Standard Deviation 14.3 |
Secondary
Cardiac Damage (Left Ventricular Hypertrophy at Echocardiogram or ECG)
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).
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypertensive Patients | Cardiac Damage (Left Ventricular Hypertrophy at Echocardiogram or ECG) | 109.6 g/m^2 | Standard Deviation 21.3 |
Secondary
Combination of Non-fatal and Fatal CV and Renal Events or 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.
Time frame: 4 years
Population: The subgroup of patients followed for the occurrence of major cardiovascular event and all-cause death
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hypertensive Patients | Combination of Non-fatal and Fatal CV and Renal Events or All-cause Death | 104 Participants |
Secondary
Renal Damage (Urine Protein)
Urine proteine (mg/24h). The increase above a certain threshold of urine protein is a sign of renal damage (see protocol).
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypertensive Patients | Renal Damage (Urine Protein) | 105.4 mg/24h | Standard Deviation 129.2 |
Secondary
Vascular Damage (Carotid Plaque at Ultrasonography)
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).
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypertensive Patients | Vascular Damage (Carotid Plaque at Ultrasonography) | 1.2 mm | Standard Deviation 0.5 |