Clinical trial NCT01454583: Registry for Ambulant Therapy With RAS-Inhibitors in Hypertension-patients in Germany
Official title: 3A-Register Zur Ambulanten Therapie Mit RAS-Inhibitoren in Patienten Mit Arterieller Hypertonie in Deutschland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Hypertension
Keywords: renin inhibitor
ACE inhibitor
ARB (AT1 receptor blockers)
RAS blockade
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2011-10-19
Enrollment: 15337
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive outpatients with arterial hypertension and treatment with a renin inhibitor, ACE inhibitor, ARB, or without RAS blockade.

In order to collect enough information on Aliskiren treatment ratio between therapy alternatives should be 4 (Aliskiren) to 1 (ACE inhibitor/ARB) to 1 (no 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.


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

Primary outcomes:
measure: Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)
timeFrame: baseline and 1 year
measure: Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP)
timeFrame: Baseline and 1 year
measure: Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)
timeFrame: Baseline and 2 years
measure: Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP)
timeFrame: Baseline and 2 years
measure: Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)
timeFrame: Baseline and 3 years
measure: Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP)
timeFrame: Baseline and 3 years
Secondary outcomes:
measure: Therapy Adherence Regarding Drug Treatment
timeFrame: Baseline and 1 year
measure: Therapy Adherence Regarding Drug Treatment
timeFrame: Baseline and 2 years
measure: Therapy Adherence Regarding Drug Treatment
timeFrame: Baseline and 3 years
measure: Adverse Events
timeFrame: 1 year follow up
measure: Adverse Events
timeFrame: 2 years follow up
measure: Adverse Events
timeFrame: 3 years follow up
measure: Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement
timeFrame: Baseline and 1 year
measure: Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement
timeFrame: Baseline and 1 year
measure: Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement
timeFrame: Baseline and 2 years
measure: Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement
timeFrame: Baseline and 2 years
measure: Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement
timeFrame: Baseline and 3 years
measure: Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement
timeFrame: Baseline and 3 years
measure: Influence of Anti-hypertensive Treatment on Renal Function
timeFrame: 1 year follow up
measure: Influence of Anti-hypertensive Treatment on Renal Function
timeFrame: 2 years follow up
measure: Influence of Anti-hypertensive Treatment on Renal Function
timeFrame: 3 years follow up
Other outcomes:
Locations:
Study officials:
affiliation: Stiftung Institut für Herzinfarktforschung
name: Uwe Zeymer, M.D.
role: STUDY_CHAIR
References:
citation: Zeymer U, Dechend R, Riemer T, Kaiser E, Senges J, Pittrow D, Schmieder RE; 3A Registry Investigators. 1-Year outcomes of hypertension management in 13,000 outpatients under practice conditions: prospective 3A registry. Int J Cardiol. 2014 Oct 20;176(3):589-94. doi: 10.1016/j.ijcard.2014.07.089. Epub 2014 Aug 1.
citation: Lehmann MV, Zeymer U, Dechend R, Kaiser E, Hagedorn I, Deeg E, Senges J, Schmieder RE. Ambulatory blood pressure monitoring: is it mandatory for blood pressure control in treated hypertensive patients?: prospective observational study. Int J Cardiol. 2013 Oct 3;168(3):2255-63. doi: 10.1016/j.ijcard.2013.01.209. Epub 2013 Mar 7.