Clinical trial NCT02128386: Medication Adherence and "True" Resistance in Patients With Resistant Hypertension
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".
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertensive Disease
Hypertension, Resistant to Conventional Therapy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2014-05-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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".

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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"
timeFrame: Week 6
Secondary outcomes:
measure: Assessment of all costs of both treatments within one year.
timeFrame: During the whole course of the study (24 weeks) and for another 24 weeks after the end of the study
measure: 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.
timeFrame: Baseline, week 6, end of study on week 24
measure: 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.
timeFrame: Week 6 - week 24
measure: Assessment of adverse events in order to evaluate the safety of both treatments.
timeFrame: During the whole course of the study (24 weeks)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Medical Outpatient Department of the Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite - Universitätsmedizin Berlin
name: Jürgen Scholze, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Reinhold Kreutz, Professor
role: PRINCIPAL_INVESTIGATOR
References: