A Study on Medication Adherence and "True" Resistance in Patients Referred to a Medical Outpatient Department in Germany With the Diagnosis "Resistant Hypertension".
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Estimation of the proportion of patients with "true" resistance among patients referred to the Medical Outpatient Department of the Charité - Universitätsmedizin Berlin with the diagnosis "resistant hypertension"
研究概览
简要总结
The purpose of this study is to estimate the proportion of patients with "true" resistance among patients referred to the Medical Outpatient Department of the Charité - Universitätsmedizin Berlin with the diagnosis "resistant hypertension". Moreover, data on medication adherence will be collected based on therapeutic drug monitoring and on the answers to validated questionnaires. Finally, efficacy, safety and costs of renal sympathetic denervation will be compared to an intensified drug treatment in an exploratory way.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male adult patients with arterial hypertension and admission diagnosis of "resistant hypertension"
- •Informed consent
- •Exclusion of secondary arterial hypertension
- •Kidney function (estimated glomerular filtration rate [eGFR] ≥ 45 ml/min/1.73 m2)
排除标准
- •Age < 18 years
- •Secondary arterial hypertension
- •Type 1 Diabetes mellitus
- •Unstable coronary heart disease, myocardial infarction or stroke in the last 6 months
- •Psychiatric diseases
- •Significant carotid stenosis (> 70%)
- •Pregnancy
- •Chronic kidney disease (eGFR < 45 ml/min/1.73 m2)
- •Severe liver injury (elevation of transaminases more than twofold the upper limit of normal)
- •Abuse of alcohol or illegal drugs
结局指标
主要结局
Estimation of the proportion of patients with "true" resistance among patients referred to the Medical Outpatient Department of the Charité - Universitätsmedizin Berlin with the diagnosis "resistant hypertension"
时间窗: Week 6
次要结局
- Assessment of adverse events in order to evaluate the safety of both treatments.(During the whole course of the study (24 weeks))
- Assessment of all costs of both treatments within one year.(During the whole course of the study (24 weeks) and for another 24 weeks after the end of the study)
- Analysis of medication adherence at baseline, after fixed-dose triple combination treatment and in the end of the study via therapeutic drug monitoring, and correlation of these results with the questionnaire findings.(Baseline, week 6, end of study on week 24)
- Explorative evaluation of the efficacy of renal sympathetic denervation compared to an intensified drug treatment based on ambulatory blood pressure and ambulatory blood pressure measurement over 24 hours.(Week 6 - week 24)
研究者
Prof. Jürgen Scholze
Head of the Medical Outpatient Department of the Charité - Universitätsmedizin Berlin
Charite University, Berlin, Germany