Medication Adherence and "True" Resistance in Patients With Resistant Hypertension

• Conditions: Hypertension, Resistant to Conventional Therapy; Hypertensive Disease

• Registration Number: NCT02128386
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-02-23
• Primary Completion: 2015-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Medical Outpatient Department of the Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany