Registry for Ambulant Therapy With RAS-Inhibitors in Hypertension-patients in Germany

Study Overview
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Brief Summary
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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.

Official Title
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3A-Register Zur Ambulanten Therapie Mit RAS-Inhibitoren in Patienten Mit Arterieller Hypertonie in Deutschland

Conditions
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Arterial Hypertension

Intervention / Treatment
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* Drug: Aliskiren
* Drug: ACE-I/ARB
* Drug: No RAS-inhibition


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aliskiren<br>Patients getting Aliskiren at baseline | Drug: Aliskiren<br>* Aliskiren (Rasilez®, Novartis) is the first clinically available substance with direct renin inhibition (DRI) which effectively lowers blood pressure.<br>* Other names: Rasilez;|
| ACE-I/ARB<br>Patients getting ACE-I (angiotensin-converting enzyme inhibitors) or ARB (angiotensin-receptor blockers) at baseline, but not Aliskiren | Drug: ACE-I/ARB<br> <br> |
| No RAS-inhibition<br>Patients getting no drugs at baseline that inhibit the renin-angiotensin-aldosterone-system (RAAS) | Drug: No RAS-inhibition<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline and 1 year | 
| 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 | Baseline and 1 year | 
| 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 | Baseline and 2 years | 
| 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 | Baseline and 2 years | 
| 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 | Baseline and 3 years | 
| 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 | Baseline and 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline and 1 year | 
| 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) | Baseline and 2 years | 
| 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) | Baseline and 3 years | 
| Adverse Events | Percentage of participants that experienced at least one adverse event during the first year of observation period | 1 year follow up | 
| Adverse Events | Percentage of participants that experienced at least one adverse event during the first two years of observation period | 2 years follow up | 
| Adverse Events | Percentage of participants that experienced at least one adverse event during the three years of observation period | 3 years follow up | 
| 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. | Baseline and 1 year | 
| 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. | Baseline and 1 year | 
| 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. | Baseline and 2 years | 
| 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. | Baseline and 2 years | 
| 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. | Baseline and 3 years | 
| 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. | Baseline and 3 years | 
| 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 | 1 year follow up | 
| 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 | 2 years follow up | 
| 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 | 3 years follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renin inhibitor, ACE inhibitor, ARB (AT1 receptor blockers), RAS blockade