Registry for Ambulant Therapy With RAS-Inhibitors in Hypertension-patients in Germany (3A)

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

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.

Study Overview

• Status: Completed
• Conditions: Arterial Hypertension
• Intervention / Treatment: Drug: Aliskiren; Drug: ACE-I/ARB; Drug: No RAS-inhibition

• Study Type: Observational
• Enrollment (Actual): 15337

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stiftung Institut fuer Herzinfarktforschung
• Collaborators: Novartis Pharmaceuticals
• Investigators: Study Chair: Uwe Zeymer, M.D., Stiftung Institut für Herzinfarktforschung

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): October 1, 2009
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: September 21, 2011
• First Submitted That Met QC Criteria: October 14, 2011
• First Posted (ESTIMATE): October 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 21, 2016
• Last Update Submitted That Met QC Criteria: June 20, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: ACE inhibitor; renin inhibitor; RAS blockade; ARB (AT1 receptor blockers)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 3A-Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO