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

• ClinicalTrials.gov Identifier: NCT01454583
• Recruitment Status: Completed
• First Posted: October 19, 2011
• Results First Posted: August 22, 2014
• Last Update Posted: July 21, 2016
• Sponsor: Stiftung Institut fuer Herzinfarktforschung
• Collaborator: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Stiftung Institut fuer Herzinfarktforschung

Study Description

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.

Condition or disease	Intervention/treatment
Arterial Hypertension	Drug: Aliskiren; Drug: ACE-I/ARB; Drug: No RAS-inhibition

Study Design

• Study Type: Observational
• Actual Enrollment: 15337 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: 3A-Register Zur Ambulanten Therapie Mit RAS-Inhibitoren in Patienten Mit Arterieller Hypertonie in Deutschland
• Study Start Date: October 2008
• Actual Primary Completion Date: October 2009
• Actual Study Completion Date: July 2012

Groups and Cohorts

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 Name: 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

Outcome Measures

Primary Outcome Measures :

1. Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) [ Time Frame: baseline and 1 year ]
   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
2. Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) [ Time Frame: Baseline and 1 year ]
   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
3. Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) [ Time Frame: Baseline and 2 years ]
   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
4. Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP) [ Time Frame: Baseline and 2 years ]
   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
5. Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) [ Time Frame: Baseline and 3 years ]
   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
6. Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) [ Time Frame: Baseline and 3 years ]
   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

Secondary Outcome Measures :

1. Therapy Adherence Regarding Drug Treatment [ Time Frame: Baseline and 1 year ]
   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)
2. Therapy Adherence Regarding Drug Treatment [ Time Frame: Baseline and 2 years ]
   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)
3. Therapy Adherence Regarding Drug Treatment [ Time Frame: Baseline and 3 years ]
   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)
4. Adverse Events [ Time Frame: 1 year follow up ]
   Percentage of participants that experienced at least one adverse event during the first year of observation period
5. Adverse Events [ Time Frame: 2 years follow up ]
   Percentage of participants that experienced at least one adverse event during the first two years of observation period
6. Adverse Events [ Time Frame: 3 years follow up ]
   Percentage of participants that experienced at least one adverse event during the three years of observation period
7. Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement [ Time Frame: Baseline and 1 year ]
   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.
8. Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement [ Time Frame: Baseline and 1 year ]
   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.
9. Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement [ Time Frame: Baseline and 2 years ]
   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.
10. Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement [ Time Frame: Baseline and 2 years ]
    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.
11. Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement [ Time Frame: Baseline and 3 years ]
    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.
12. Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement [ Time Frame: Baseline and 3 years ]
    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.
13. Influence of Anti-hypertensive Treatment on Renal Function [ Time Frame: 1 year follow up ]
    Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline
14. Influence of Anti-hypertensive Treatment on Renal Function [ Time Frame: 2 years follow up ]
    Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline
15. Influence of Anti-hypertensive Treatment on Renal Function [ Time Frame: 3 years follow up ]
    Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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)

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

Contacts and Locations

Sponsors and Collaborators

Stiftung Institut fuer Herzinfarktforschung

Novartis Pharmaceuticals

Investigators

• Study Chair: Uwe Zeymer, M.D.; Stiftung Institut für Herzinfarktforschung

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Stiftung Institut fuer Herzinfarktforschung
• ClinicalTrials.gov Identifier: NCT01454583
• Other Study ID Numbers: 3A-Registry
• First Posted: October 19, 2011
• Results First Posted: August 22, 2014
• Last Update Posted: July 21, 2016
• Last Verified: June 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:

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

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases