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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01454583
First received: September 21, 2011
Last updated: October 14, 2011
Last verified: October 2011
History of Changes
  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
Arterial Hypertension

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:

U.S. FDA Resources

Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Primary Outcome Measures:
  • Characterization of consecutive outpatients with arterial hypertension and medical treatment in Germany [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterization of consecutive outpatients with arterial hypertension and treatment with Aliskiren in Germany [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Guideline adherence in diagnosis and treatment of consecutive outpatients with arterial hypertension in Germany [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Therapy adherence regarding drug treatment [ Time Frame: 1 year follow up ] [ Designated as safety issue: No ]
  • Therapy adherence regarding drug treatment [ Time Frame: 2 years follow up ] [ Designated as safety issue: No ]
  • Therapy adherence regarding drug treatment [ Time Frame: 3 years follow up ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 1 year follow up ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: 2 years follow up ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: 3 years follow up ] [ Designated as safety issue: Yes ]
  • Therapeutic success of hypertension treatment as measured by 24-hour blood pressure measurement [ Time Frame: 1 year follow up ] [ Designated as safety issue: No ]
  • Therapeutic success of hypertension treatment as measured by 24-hour blood pressure measurement [ Time Frame: 2 years follow up ] [ Designated as safety issue: No ]
  • Therapeutic success of hypertension treatment as measured by 24-hour blood pressure measurement [ Time Frame: 3 years follow up ] [ Designated as safety issue: No ]
  • Influence of anti-hypertensive treatment on renal function [ Time Frame: 1 year follow up ] [ Designated as safety issue: Yes ]
    Assessment of influence on renal function, prevalence of renal dysfunction, prognostic effect of renal dysfunctions


Enrollment: 14998
Study Start Date: October 2008
Estimated Study Completion Date: July 2012
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  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
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

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
Last Updated: October 14, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
renin inhibitor
ACE inhibitor
ARB
RAS blockade

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013