An observational study in Hypertensive Disease and Hypertension, Resistant to Conventional Therapy, sponsored by Charite University, Berlin, Germany. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-23.
Sponsored by Charite University, Berlin, Germany · Observational
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.
6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's planned enrollment of 50 is below the median of 210 across 1,358 observational studies indexed under Hypertension.
Browse Hypertension studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
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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".
Inclusion Criteria:
Exclusion Criteria:
Olmesartan 40 mg once daily + Amlodipine 5 or 10 mg once daily + Hydrochlorothiazide 25 mg one daily plus renal sympathetic denervation
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)
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"
Time frame: Week 6
Assessment of all costs of both treatments within one year.
Time frame: 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.
Time frame: 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.
Time frame: Week 6 - week 24
Assessment of adverse events in order to evaluate the safety of both treatments.
Time frame: During the whole course of the study (24 weeks)
This study is status unknown, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany