3A-Register Zur Ambulanten Therapie Mit RAS-Inhibitoren in Patienten Mit Arterieller Hypertonie in Deutschland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15,337
- 主要终点
- Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treatment as outpatient
- •arterial hypertension
- •treatment with a renin inhibitor, ACE inhibitor, ARB, or without RAS blockade
- •informed consent
排除标准
- •foreseeable difficulties to perform follow up
研究组 & 干预措施
Aliskiren
Patients getting Aliskiren at baseline
干预措施: Aliskiren (Drug)
ACE-I/ARB
Patients getting ACE-I (angiotensin-converting enzyme inhibitors) or ARB (angiotensin-receptor blockers) at baseline, but not Aliskiren
干预措施: ACE-I/ARB (Drug)
No RAS-inhibition
Patients getting no drugs at baseline that inhibit the renin-angiotensin-aldosterone-system (RAAS)
干预措施: No RAS-inhibition (Drug)
结局指标
主要结局
Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)
时间窗: 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)
时间窗: 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)
时间窗: 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
次要结局
- Therapy Adherence Regarding Drug Treatment(Baseline and 3 years)
- Adverse Events(3 years follow up)
- Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement(Baseline and 3 years)
- Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement(Baseline and 3 years)
- Influence of Anti-hypertensive Treatment on Renal Function(3 years follow up)