Medication Adherence and True Resistance in Patients With Resistant Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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A Study on Medication Adherence and True Resistance in Patients Referred to a Medical Outpatient Department in Germany With the Diagnosis Resistant Hypertension.

Conditions
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Hypertensive Disease, Hypertension, Resistant to Conventional Therapy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Renal sympathetic denervation<br>Olmesartan 40 mg once daily + Amlodipine 5 or 10 mg once daily + Hydrochlorothiazide 25 mg one daily plus renal sympathetic denervation | |
| Intensified antihypertensive treatment<br>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) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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) |