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

Arterial Hypertension Clinical Trial

— 3A  

Official title:

3A-Register Zur Ambulanten Therapie Mit RAS-Inhibitoren in Patienten Mit Arterieller Hypertonie in Deutschland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454583
• Other study ID #: 3A-Registry
• Status: Completed
• Phase: N/A
• First received: September 21, 2011
• Last updated: August 5, 2014
• Start date: October 2008
• Est. completion date: July 2012

Study information

• Verified date: August 2014
• Source: Stiftung Institut fuer Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15337
• Est. completion date: July 2012
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension

Intervention

Drug:
• Aliskiren
Aliskiren (Rasilez®, Novartis) is the first clinically available substance with direct renin inhibition (DRI) which effectively lowers blood pressure.
• ACE-I/ARB

• No RAS-inhibition

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stiftung Institut fuer Herzinfarktforschung	Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline and 1 year	No
Primary	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	Baseline and 1 year	No
Primary	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	Baseline and 2 years	No
Primary	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	Baseline and 2 years	No
Primary	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	Baseline and 3 years	No
Primary	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	Baseline and 3 years	No
Secondary	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)	Baseline and 1 year	No
Secondary	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)	Baseline and 2 years	No
Secondary	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)	Baseline and 3 years	No
Secondary	Adverse Events	Percentage of participants that experienced at least one adverse event during the first year of observation period	1 year follow up	Yes
Secondary	Adverse Events	Percentage of participants that experienced at least one adverse event during the first two years of observation period	2 years follow up	Yes
Secondary	Adverse Events	Percentage of participants that experienced at least one adverse event during the three years of observation period	3 years follow up	Yes
Secondary	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.	Baseline and 1 year	No
Secondary	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.	Baseline and 1 year	No
Secondary	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.	Baseline and 2 years	No
Secondary	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.	Baseline and 2 years	No
Secondary	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.	Baseline and 3 years	No
Secondary	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.	Baseline and 3 years	No
Secondary	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	1 year follow up	Yes
Secondary	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	2 years follow up	Yes
Secondary	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	3 years follow up	Yes