Hypertension, Resistant to Conventional Therapy, Hypertensive Disease
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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. | 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) |
Countries
Germany
Contacts
Primary ContactJürgen Scholze, Professor
Backup ContactReinhold Kreutz, Professor
Outcome results
None listed