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

June 20, 2016 updated by: Stiftung Institut fuer Herzinfarktforschung

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15337

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline and 1 year
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
Baseline and 1 year
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
Baseline and 2 years
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
Baseline and 2 years
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
Baseline and 3 years
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
Baseline and 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Baseline and 1 year
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)
Baseline and 2 years
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)
Baseline and 3 years
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
1 year follow up
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
2 years follow up
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
3 years follow up
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.
Baseline and 1 year
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.
Baseline and 1 year
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.
Baseline and 2 years
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.
Baseline and 2 years
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.
Baseline and 3 years
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.
Baseline and 3 years
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
1 year follow up
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
2 years follow up
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
3 years follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stiftung Institut fuer Herzinfarktforschung

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Uwe Zeymer, M.D., Stiftung Institut für Herzinfarktforschung

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3A-Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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