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

Hypertension, Resistant to Conventional Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02128386
• Other study ID #: EA1/328/13
• Status: Recruiting
• Phase: N/A
• First received: April 29, 2014
• Last updated: February 20, 2015
• Start date: February 2014
• Est. completion date: March 2016

Study information

• Verified date: February 2015
• Source: Charite University, Berlin, Germany
• Contact: Jürgen Scholze, Professor
• Email: juergen.scholze[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Vasospasm
• Hypertension
• Hypertension, Resistant to Conventional Therapy
• Hypertensive Disease

Locations

Country	Name	City	State
Germany	Medical Outpatient Department of the Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Assessment of adverse events in order to evaluate the safety of both treatments.		During the whole course of the study (24 weeks)	Yes