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

Completed

• Conditions: Arterial Hypertension
• Interventions: Drug: ACE-I/ARB; Drug: No RAS-inhibition; Drug: Aliskiren

• Registration Number: NCT01454583
• Lead Sponsor: Stiftung Institut fuer Herzinfarktforschung

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2009-10
• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-10-14
• Study First Posted: 2011-10-19
• Study Completion: 2012-07
• Results First Submitted: 2013-08-15
• Results First Submitted QC: 2014-08-05
• Results First Posted: 2014-08-22
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-20
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15337

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ACE-I/ARB	ACE-I/ARB	Patients getting ACE-I (angiotensin-converting enzyme inhibitors) or ARB (angiotensin-receptor blockers) at baseline, but not Aliskiren
No RAS-inhibition	No RAS-inhibition	Patients getting no drugs at baseline that inhibit the renin-angiotensin-aldosterone-system (RAAS)
Aliskiren	Aliskiren	Patients getting Aliskiren at baseline

Primary Outcome Measures

Name	Time	Method
Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)	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)	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
Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP)	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

Secondary Outcome Measures

Name	Time	Method
Adverse Events	3 years follow up	Percentage of participants that experienced at least one adverse event during the three years of observation period
Therapy Adherence Regarding Drug Treatment	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)
Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement	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.
Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement	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.
Influence of Anti-hypertensive Treatment on Renal Function	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