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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Jürgen Scholze, Professor; Email: juergen.scholze@charite.de
• Study Contact Backup: Name: Reinhold Kreutz, Professor; Email: reinhold.kreutz@charite.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Medical Outpatient Department of the Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult male or female patients referred to the Medical Outpatient Department of the Charité - Universitätsmedizin Berlin with the diagnosis "Resistant hypertension".

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Jürgen Scholze, Professor, Charite - Universitatsmedizin Berlin; Principal Investigator: Reinhold Kreutz, Professor, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: April 30, 2014
• First Posted (Estimate): May 1, 2014

Study Record Updates

• Last Update Posted (Estimate): February 23, 2015
• Last Update Submitted That Met QC Criteria: February 20, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: EA1/328/13