Arterial Hypertension3ANCT01454583

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

An observational study of Arterial Hypertension, run by Stiftung Institut fuer Herzinfarktforschung.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Arterial Hypertension
What is being tested?: Aliskiren, ACE-I/ARB and No RAS-inhibition
How many people: 15,337 participants
Where: No sites listed yet
Study dates: Oct 2008to Jul 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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)

Who may be able to join

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

Who cannot join

foreseeable difficulties to perform follow up

About this study

Official title: 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.

Conditions: Arterial Hypertension
Being tested: Aliskiren, ACE-I/ARB, No RAS-inhibition
Keywords: renin inhibitor, ACE inhibitor, ARB (AT1 receptor blockers), RAS blockade
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AliskirenDrug
Also called Rasilez
Aliskiren (Rasilez®, Novartis) is the first clinically available substance with direct renin inhibition (DRI) which effectively lowers blood pressure.
ACE-I/ARBDrug
No RAS-inhibitionDrug

Study groups in NCT01454583
Study group	Role	What they receive
Aliskiren		Patients getting Aliskiren at baseline Receives: Drug: Aliskiren
ACE-I/ARB		Patients getting ACE-I (angiotensin-converting enzyme inhibitors) or ARB (angiotensin-receptor blockers) at baseline, but not Aliskiren Receives: Drug: ACE-I/ARB
No RAS-inhibition		Patients getting no drugs at baseline that inhibit the renin-angiotensin-aldosterone-system (RAAS) Receives: Drug: No RAS-inhibition

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 3 years

Secondary outcomes (15)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Jul 2012

First posted19 Oct 2011 (estimated)
Study startOct 2008
Primary completionOct 2009
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Arterial HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 15,337 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01454583
Sponsor's protocol ID: 3A-Registry
Acronym: 3A
Status last verified: Jun 2016
First submitted: 21 Sep 2011
Last updated: 21 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 25305705
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.
PubMed 23474245

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 3A-Register Zur Ambulanten Therapie Mit RAS-Inhibitoren in Patienten Mit Arterieller Hypertonie in Deutschland
ClinicalTrials.gov ID: NCT01454583
Acronym / sponsor ID: 3A / 3A-Registry
Conditions: Arterial Hypertension
Keywords: renin inhibitor, ACE inhibitor, ARB (AT1 receptor blockers), RAS blockade
Study type: Observational
Recruitment status: Completed
Enrolment: 15,337 participants (actual)
Lead sponsor: Stiftung Institut fuer HerzinfarktforschungUniversity, hospital or other
Collaborators: Novartis Pharmaceuticals
Study start: Oct 2008
Primary completion: Oct 2009 (actual)
Study completion: Jul 2012 (actual)
First posted: 19 Oct 2011 (estimated)
Results: Posted 22 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Patients fulfilling the relevant criteria are enrolled and followed up by their general practitioner or medical specialist.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Aliskiren	–	Drug: AliskirenPatients getting Aliskiren at baseline
ACE-I/ARB	–	Drug: ACE-I/ARBPatients getting ACE-I (angiotensin-converting enzyme inhibitors) or ARB (angiotensin-receptor blockers) at baseline, but not Aliskiren
No RAS-inhibition	–	Drug: No RAS-inhibitionPatients getting no drugs at baseline that inhibit the renin-angiotensin-aldosterone-system (RAAS)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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)

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

foreseeable difficulties to perform follow up

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AliskirenAlso: RasilezAliskiren (Rasilez®, Novartis) is the first clinically available substance with direct renin inhibition (DRI) which effectively lowers blood pressure.	Drug	Aliskiren
ACE-I/ARB	Drug	ACE-I/ARB
No RAS-inhibition	Drug	No RAS-inhibition

Primary outcome

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
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
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
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
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
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

15 secondary outcomes

Therapy Adherence Regarding Drug Treatment
Time frame: Baseline and 1 year
Therapy Adherence Regarding Drug Treatment
Time frame: Baseline and 2 years
Therapy Adherence Regarding Drug Treatment
Time frame: Baseline and 3 years
Adverse Events
Time frame: 1 year follow up
Adverse Events
Time frame: 2 years follow up
Adverse Events
Time frame: 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
Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement
Time frame: 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
Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement
Time frame: 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
Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement
Time frame: Baseline and 3 years
Influence of Anti-hypertensive Treatment on Renal Function
Time frame: 1 year follow up
Influence of Anti-hypertensive Treatment on Renal Function
Time frame: 2 years follow up
Influence of Anti-hypertensive Treatment on Renal Function
Time frame: 3 years follow up

Results and safety

Results posted to the registry on 22 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aliskiren	10,177	9,120
ACE-I/ARB	2,696	2,378
No RAS-inhibition	2,113	1,933

Primary outcome: Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)

Time frame: baseline and 1 year. Mean (Standard Deviation). Unit: percent change

Measure	Group A n = 8880	Group B n = 2321	Group C n = 1896
Value	11.8 (12.5)	9.7 (12.4)	9.9 (12.8)

Primary outcome: Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP)

Time frame: Baseline and 1 year. Mean (Standard Deviation). Unit: percent change

Measure	Group A n = 8880	Group B n = 2321	Group C n = 1896
Value	8.9 (13.0)	7.7 (12.9)	8.0 (13.5)

Primary outcome: Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)

Time frame: Baseline and 2 years. Mean (Standard Deviation). Unit: percent change

Measure	Group A n = 6055	Group B n = 1610	Group C n = 1345
Value	12.8 (12.9)	10.0 (13.5)	10.4 (12.7)

Population analysed: Patients with RR measurement at baseline and 2 years follow-up

Primary outcome: Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP)

Time frame: Baseline and 2 years. Mean (Standard Deviation). Unit: percent change

Measure	Group A n = 6054	Group B n = 1609	Group C n = 1345
Value	10.3 (13.0)	8.5 (13.5)	8.9 (13.4)

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to 2 years follow up. Other adverse events reported at 0.1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	649 of 10,177 (6.4%)	211 of 10,177 (2.1%)	Not reported
Group B	136 of 2,696 (5%)	41 of 2,696 (1.5%)	Not reported
Group C	84 of 2,113 (4%)	14 of 2,113 (0.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25305705Zeymer 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.
Derived from this study: PubMed 23474245Lehmann 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Uwe Zeymer, M.D. study chair

Stiftung Institut für Herzinfarktforschung

Questions about this trial

What is this clinical trial studying?

An observational study of Arterial Hypertension, run by Stiftung Institut fuer Herzinfarktforschung.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP) (time frame: baseline and 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01454583, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2016.