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

NCT01454583 | Completed Results

• 1 other identifier: 3A-Registry
• Study Type: observational
• Target: 15,337
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arterial Hypertension

Keywords

renin inhibitor; ACE inhibitor; ARB (AT1 receptor blockers); RAS blockade

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (15)

• Therapy Adherence Regarding Drug Treatment

  Baseline and 1 year

• Therapy Adherence Regarding Drug Treatment

  Baseline and 2 years

• Therapy Adherence Regarding Drug Treatment

  Baseline and 3 years

• Adverse Events

  1 year follow up

• Adverse Events

  2 years follow up

Study Arms (3)

Aliskiren

Patients getting Aliskiren at baseline

Drug: Aliskiren

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

Interventions

Aliskiren DRUG

Aliskiren (Rasilez®, Novartis) is the first clinically available substance with direct renin inhibition (DRI) which effectively lowers blood pressure.

Also known as: Rasilez

Aliskiren

ACE-I/ARB DRUG

ACE-I/ARB

No RAS-inhibition DRUG

No RAS-inhibition

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• treatment as outpatient
• arterial hypertension
• treatment with a renin inhibitor, ACE inhibitor, ARB, or without RAS blockade
• informed consent

You may not qualify if:

• foreseeable difficulties to perform follow up

Sponsors & Collaborators

• Stiftung Institut fuer Herzinfarktforschung: lead
• Novartis Pharmaceuticals: collaborator

Related Publications (2)

• 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.

  PMID: 25305705 DERIVED

• 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.

  PMID: 23474245 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Professor Dr. Uwe Zeymer
• Organization: Foundation Stiftung Institut fuer Herzinfarktforschung Ludwigshafen, Germany

Uwe.Zeymer@t-online.de

+49 621 503 2813

Study Officials

• Uwe Zeymer, M.D.

  Stiftung Institut für Herzinfarktforschung

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: October 19, 2011
• Study Start: October 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: July 1, 2012
• Last Updated: July 21, 2016
• Results First Posted: August 22, 2014

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share