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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal sympathetic denervation | Olmesartan 40 mg once daily + Amlodipine 5 or 10 mg once daily + Hydrochlorothiazide 25 mg one daily plus renal sympathetic denervation | ||
| Intensified antihypertensive treatment | Olmesartan 40 mg once daily + Amlodipine 5 or 10 mg once daily + Hydrochlorothiazide 25 mg one daily plus second-line antihypertensive agents (e.g. mineralocorticoid receptor antagonists or alpha-1-blockers) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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" | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult male or female patients referred to the Medical Outpatient Department of the Charité - Universitätsmedizin Berlin with the diagnosis "Resistant hypertension".
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jürgen Scholze, Professor | Contact | juergen.scholze@charite.de | ||
| Reinhold Kreutz, Professor | Contact | reinhold.kreutz@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Jürgen Scholze, Professor | Charite - Universitätsmedizin Berlin | Principal Investigator |
| Reinhold Kreutz, Professor | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Outpatient Department of the Charité - Universitätsmedizin Berlin | Recruiting | Berlin | 10117 | Germany |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| C563514 | Hypertension Resistant to Conventional Therapy |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Blood samples for therapeutic drug monitoring
| 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 |
| Assessment of adverse events in order to evaluate the safety of both treatments. | During the whole course of the study (24 weeks) |