Arterial Hypertension
Conditions
Keywords
renin inhibitor, ACE inhibitor, ARB (AT1 receptor blockers), RAS blockade
Brief summary
In Germany nearly half of the population present elevated values of blood pressure, with - as a result of lifestyle factors and a growing average age - further increasing numbers. Consequences of arterial hypertension may be cardiovascular diseases, cerebrovascular events, and renal insufficiency. Thus, hypertension therapy focuses on the reduction of these complications. The aims of the 3A-registry are the characterization of outpatients with hypertension, their diagnostic procedures and medical treatment (esp. with renin inhibitors), therapy compliance and success, clinical events, and an assessment of overall guideline adherence in the treatment of these patients. Patients fulfilling the relevant criteria are enrolled and followed up by their general practitioner or medical specialist.
Interventions
DRUGAliskiren
Aliskiren (Rasilez®, Novartis) is the first clinically available substance with direct renin inhibition (DRI) which effectively lowers blood pressure.
DRUGACE-I/ARB
DRUGNo RAS-inhibition
Sponsors
Novartis Pharmaceuticals
Stiftung Institut fuer Herzinfarktforschung
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* treatment as outpatient * arterial hypertension * treatment with a renin inhibitor, ACE inhibitor, ARB, or without RAS blockade * informed consent
Exclusion criteria
* foreseeable difficulties to perform follow up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) | baseline and 1 year | Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 1 year, the difference divided by the baseline value, multiplied by 100 |
| Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) | Baseline and 1 year | Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100 |
| Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP) | Baseline and 2 years | Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement | Baseline and 1 year | Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h. |
| Therapy Adherence Regarding Drug Treatment | Baseline and 1 year | Percentage of patients not having changed the therapy group after 1 year (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline) |
| Influence of Anti-hypertensive Treatment on Renal Function | 1 year follow up | Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline |
| Adverse Events | 1 year follow up | Percentage of participants that experienced at least one adverse event during the first year of observation period |
| Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement | Baseline and 1 year | Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A Patients treated with Aliskiren (DRI) | 10,177 |
| Group B Patients treated with ACE-I or ARB (ARB/ACE-I) | 2,696 |
| Group C Patients without any RAS inhibition (No-RAS-I) | 2,113 |
| Total | 14,986 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 1st Year | Lost to Follow-up | 1,057 | 318 | 180 |
| 2nd Year | Lost to Follow-up | 3,965 | 1,049 | 737 |
| 3rd Year | Lost to Follow-up | 1,959 | 512 | 297 |
Baseline characteristics
| Characteristic | Group A | Group B | Group C | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5068 Participants | 1396 Participants | 932 Participants | 7396 Participants |
| Age, Categorical Between 18 and 65 years | 5109 Participants | 1300 Participants | 1181 Participants | 7590 Participants |
| Age, Continuous | 63.6 years STANDARD_DEVIATION 12.06 | 63.7 years STANDARD_DEVIATION 11.92 | 61.3 years STANDARD_DEVIATION 13.36 | 63.3 years STANDARD_DEVIATION 12.26 |
| Sex: Female, Male Female | 4658 Participants | 1229 Participants | 1085 Participants | 6972 Participants |
| Sex: Female, Male Male | 5519 Participants | 1467 Participants | 1028 Participants | 8014 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 211 / 10,177 | 41 / 2,696 | 14 / 2,113 |
| serious Total, serious adverse events | 649 / 10,177 | 136 / 2,696 | 84 / 2,113 |
Outcome results
Primary
Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP)
Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100
Time frame: Baseline and 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) | 8.9 percent change | Standard Deviation 13 |
| Group B | Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) | 7.7 percent change | Standard Deviation 12.9 |
| Group C | Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) | 8.0 percent change | Standard Deviation 13.5 |
Primary
Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP)
Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 3 years, the difference divided by the baseline value, multiplied by 100
Time frame: Baseline and 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) | 9.1 percent change | Standard Deviation 13.6 |
| Group B | Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) | 6.2 percent change | Standard Deviation 14.2 |
| Group C | Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) | 6.4 percent change | Standard Deviation 14.2 |
Primary
Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP)
Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100
Time frame: Baseline and 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP) | 10.3 percent change | Standard Deviation 13 |
| Group B | Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP) | 8.5 percent change | Standard Deviation 13.5 |
| Group C | Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP) | 8.9 percent change | Standard Deviation 13.4 |
Primary
Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)
Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 3 years, the difference divided by the baseline value, multiplied by 100
Time frame: Baseline and 3 years
Population: Patients with DM or HF and RR measurement at baseline and 3 years follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) | 12.0 percent change | Standard Deviation 13.4 |
| Group B | Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) | 8.9 percent change | Standard Deviation 14.2 |
| Group C | Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) | 9.4 percent change | Standard Deviation 13.1 |
Primary
Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)
Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 1 year, the difference divided by the baseline value, multiplied by 100
Time frame: baseline and 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) | 11.8 percent change | Standard Deviation 12.5 |
| Group B | Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) | 9.7 percent change | Standard Deviation 12.4 |
| Group C | Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) | 9.9 percent change | Standard Deviation 12.8 |
Primary
Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)
Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 2 years, the difference divided by the baseline value, multiplied by 100
Time frame: Baseline and 2 years
Population: Patients with RR measurement at baseline and 2 years follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) | 12.8 percent change | Standard Deviation 12.9 |
| Group B | Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) | 10.0 percent change | Standard Deviation 13.5 |
| Group C | Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) | 10.4 percent change | Standard Deviation 12.7 |
Secondary
Adverse Events
Percentage of participants that experienced at least one adverse event during the first year of observation period
Time frame: 1 year follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Adverse Events | 5.3 percentage of patients |
| Group B | Adverse Events | 4.1 percentage of patients |
| Group C | Adverse Events | 3.4 percentage of patients |
Secondary
Adverse Events
Percentage of participants that experienced at least one adverse event during the first two years of observation period
Time frame: 2 years follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Adverse Events | 7.2 percentage of patients |
| Group B | Adverse Events | 6.6 percentage of patients |
| Group C | Adverse Events | 5.3 percentage of patients |
Secondary
Adverse Events
Percentage of participants that experienced at least one adverse event during the three years of observation period
Time frame: 3 years follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Adverse Events | 12.9 percentage of patients |
| Group B | Adverse Events | 12.6 percentage of patients |
| Group C | Adverse Events | 9.5 percentage of patients |
Secondary
Influence of Anti-hypertensive Treatment on Renal Function
Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline
Time frame: 3 years follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Influence of Anti-hypertensive Treatment on Renal Function | 32.7 percentage of patients |
| Group B | Influence of Anti-hypertensive Treatment on Renal Function | 28.2 percentage of patients |
| Group C | Influence of Anti-hypertensive Treatment on Renal Function | 28.6 percentage of patients |
Secondary
Influence of Anti-hypertensive Treatment on Renal Function
Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline
Time frame: 1 year follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Influence of Anti-hypertensive Treatment on Renal Function | 33.5 percentage of patients |
| Group B | Influence of Anti-hypertensive Treatment on Renal Function | 32.1 percentage of patients |
| Group C | Influence of Anti-hypertensive Treatment on Renal Function | 34.1 percentage of patients |
Secondary
Influence of Anti-hypertensive Treatment on Renal Function
Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline
Time frame: 2 years follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Influence of Anti-hypertensive Treatment on Renal Function | 32.8 percentage of patients |
| Group B | Influence of Anti-hypertensive Treatment on Renal Function | 32.6 percentage of patients |
| Group C | Influence of Anti-hypertensive Treatment on Renal Function | 33.9 percentage of patients |
Secondary
Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement
Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.
Time frame: Baseline and 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement | 6.5 percent change | Standard Deviation 11.9 |
| Group B | Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement | 5.2 percent change | Standard Deviation 11.4 |
| Group C | Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement | 5.9 percent change | Standard Deviation 10.1 |
Secondary
Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement
Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 2 years, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.
Time frame: Baseline and 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement | 7.7 percent change | Standard Deviation 12 |
| Group B | Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement | 5.6 percent change | Standard Deviation 14.6 |
| Group C | Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement | 6.7 percent change | Standard Deviation 11.2 |
Secondary
Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement
Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 3 years, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.
Time frame: Baseline and 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement | 5.4 percent change | Standard Deviation 14.8 |
| Group B | Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement | 5.3 percent change | Standard Deviation 12.4 |
| Group C | Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement | 6.4 percent change | Standard Deviation 11.4 |
Secondary
Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement
Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 2 years, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.
Time frame: Baseline and 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement | 8.3 percent change | Standard Deviation 10.7 |
| Group B | Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement | 6.6 percent change | Standard Deviation 11.1 |
| Group C | Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement | 7.2 percent change | Standard Deviation 9.1 |
Secondary
Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement
Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.
Time frame: Baseline and 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement | 7.0 percent change | Standard Deviation 10 |
| Group B | Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement | 5.9 percent change | Standard Deviation 10 |
| Group C | Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement | 5.3 percent change | Standard Deviation 8.6 |
Secondary
Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement
Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 3 years, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.
Time frame: Baseline and 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement | 7.9 percent change | Standard Deviation 12.4 |
| Group B | Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement | 6.1 percent change | Standard Deviation 11.2 |
| Group C | Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement | 7.3 percent change | Standard Deviation 11.8 |
Secondary
Therapy Adherence Regarding Drug Treatment
Percentage of patients not having changed the therapy group after 1 year (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)
Time frame: Baseline and 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Therapy Adherence Regarding Drug Treatment | 92.8 percentage of patients |
| Group B | Therapy Adherence Regarding Drug Treatment | 94.9 percentage of patients |
| Group C | Therapy Adherence Regarding Drug Treatment | 85.0 percentage of patients |
Secondary
Therapy Adherence Regarding Drug Treatment
Percentage of patients not having changed the therapy group after 2 years (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)
Time frame: Baseline and 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Therapy Adherence Regarding Drug Treatment | 85.2 percentage of patients |
| Group B | Therapy Adherence Regarding Drug Treatment | 89.7 percentage of patients |
| Group C | Therapy Adherence Regarding Drug Treatment | 72.5 percentage of patients |
Secondary
Therapy Adherence Regarding Drug Treatment
Percentage of patients not having changed the therapy group after 3 years (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)
Time frame: Baseline and 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Therapy Adherence Regarding Drug Treatment | 65.8 percentage of patients |
| Group B | Therapy Adherence Regarding Drug Treatment | 82.1 percentage of patients |
| Group C | Therapy Adherence Regarding Drug Treatment | 60.7 percentage of patients |