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

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01454583
First received: September 21, 2011
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention
Arterial Hypertension
Drug: Aliskiren
Drug: ACE-I/ARB
Drug: No RAS-inhibition

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 3A-Register Zur Ambulanten Therapie Mit RAS-Inhibitoren in Patienten Mit Arterieller Hypertonie in Deutschland

Resource links provided by NLM:


Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Primary Outcome Measures:
  • Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
    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

  • Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    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

  • Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]
    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

  • Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP) [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]
    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

  • Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) [ Time Frame: Baseline and 3 years ] [ Designated as safety issue: No ]
    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

  • Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP) [ Time Frame: Baseline and 3 years ] [ Designated as safety issue: No ]
    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:
  • Therapy Adherence Regarding Drug Treatment [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    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)

  • Therapy Adherence Regarding Drug Treatment [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]
    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)

  • Therapy Adherence Regarding Drug Treatment [ Time Frame: Baseline and 3 years ] [ Designated as safety issue: No ]
    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)

  • Adverse Events [ Time Frame: 1 year follow up ] [ Designated as safety issue: Yes ]
    Percentage of participants that experienced at least one adverse event during the first year of observation period

  • Adverse Events [ Time Frame: 2 years follow up ] [ Designated as safety issue: Yes ]
    Percentage of participants that experienced at least one adverse event during the first two years of observation period

  • Adverse Events [ Time Frame: 3 years follow up ] [ Designated as safety issue: Yes ]
    Percentage of participants that experienced at least one adverse event during the three years of observation period

  • Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    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.

  • Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    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.

  • Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]
    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.

  • Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]
    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.

  • Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement [ Time Frame: Baseline and 3 years ] [ Designated as safety issue: No ]
    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.

  • Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement [ Time Frame: Baseline and 3 years ] [ Designated as safety issue: No ]
    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.

  • Influence of Anti-hypertensive Treatment on Renal Function [ Time Frame: 1 year follow up ] [ Designated as safety issue: Yes ]
    Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline

  • Influence of Anti-hypertensive Treatment on Renal Function [ Time Frame: 2 years follow up ] [ Designated as safety issue: Yes ]
    Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline

  • Influence of Anti-hypertensive Treatment on Renal Function [ Time Frame: 3 years follow up ] [ Designated as safety issue: Yes ]
    Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline


Enrollment: 15337
Study Start Date: October 2008
Study Completion Date: July 2012
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454583

Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Novartis Pharmaceuticals
Investigators
Study Chair: Uwe Zeymer, M.D. Stiftung Institut für Herzinfarktforschung
  More Information

No publications provided by Stiftung Institut fuer Herzinfarktforschung

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT01454583     History of Changes
Other Study ID Numbers: 3A-Registry
Study First Received: September 21, 2011
Results First Received: August 15, 2013
Last Updated: August 5, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
renin inhibitor
ACE inhibitor
ARB (AT1 receptor blockers)
RAS blockade

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014