N/A
N=14,986
Registry for Ambulant Therapy With RAS-Inhibitors in Hypertension-patients in Germany
Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01454583 ↗Enrolled (actual)
14,986
Serious AEs
5.8%
Results posted
Aug 2014
Primary outcome: Primary: Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) — 11.8; 9.7; 9.9 percent change
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Aliskiren (Drug); ACE-I/ARB (Drug); No RAS-inhibition (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Stiftung Institut fuer Herzinfarktforschung
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) |
12.0; 8.9; 9.4 | — |
| PRIMARY Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) |
9.1; 6.2; 6.4 | — |
| PRIMARY Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) |
12.0; 8.9; 9.4 | — |
| PRIMARY Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP) |
10.3; 8.5; 8.9 | — |
| PRIMARY Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) |
12.0; 8.9; 9.4 | — |
| PRIMARY Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) |
9.1; 6.2; 6.4 | — |
| SECONDARY Therapy Adherence Regarding Drug Treatment |
65.8; 82.1; 60.7 | — |
| SECONDARY Therapy Adherence Regarding Drug Treatment |
65.8; 82.1; 60.7 | — |
| SECONDARY Therapy Adherence Regarding Drug Treatment |
65.8; 82.1; 60.7 | — |
| SECONDARY Adverse Events |
12.9; 12.6; 9.5 | — |
| SECONDARY Adverse Events |
12.9; 12.6; 9.5 | — |
| SECONDARY Adverse Events |
12.9; 12.6; 9.5 | — |
| SECONDARY Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement |
7.9; 6.1; 7.3 | — |
| SECONDARY Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement |
5.4; 5.3; 6.4 | — |
| SECONDARY Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement |
7.9; 6.1; 7.3 | — |
| SECONDARY Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement |
5.4; 5.3; 6.4 | — |
| SECONDARY Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement |
7.9; 6.1; 7.3 | — |
| SECONDARY Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement |
5.4; 5.3; 6.4 | — |
| SECONDARY Influence of Anti-hypertensive Treatment on Renal Function |
32.7; 28.2; 28.6 | — |
| SECONDARY Influence of Anti-hypertensive Treatment on Renal Function |
32.7; 28.2; 28.6 | — |
| SECONDARY Influence of Anti-hypertensive Treatment on Renal Function |
32.7; 28.2; 28.6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01454583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.