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

NCT ID: NCT02128386

Last Updated: 2015-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-03-31

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.

Detailed Description

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Conditions

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Hypertensive Disease Hypertension, Resistant to Conventional Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Renal sympathetic denervation

Olmesartan 40 mg once daily + Amlodipine 5 or 10 mg once daily + Hydrochlorothiazide 25 mg one daily plus renal sympathetic denervation

No interventions assigned to this group

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)

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Prof. Jürgen Scholze

Head of the Medical Outpatient Department of the Charité - Universitätsmedizin Berlin

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jürgen Scholze, Professor

Role: PRINCIPAL_INVESTIGATOR

Charite - Universitätsmedizin Berlin

Reinhold Kreutz, Professor

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Medical Outpatient Department of the Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jürgen Scholze, Professor

Role: CONTACT

Reinhold Kreutz, Professor

Role: CONTACT

Other Identifiers

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EA1/328/13

Identifier Type: -

Identifier Source: org_study_id

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