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Completed

NCT Number: NCT01454583

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

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.

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Key information

Conditions

Arterial Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aliskiren

Drug

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

Drug

No RAS-inhibition

Drug

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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

  15. 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

Sponsors and collaborators

Lead sponsor

Stiftung Institut fuer Herzinfarktforschung

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study title

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

Acronym: 3A

Important dates

Study start
2008
Primary completion
2009
Study completion
2012
First posted
Oct 19, 2011
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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