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

NCT02128386 | Unknown

• 1 other identifier: EA1/328/13
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertensive Disease; Hypertension, Resistant to Conventional Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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".

You may qualify if:

• Female or male adult patients with arterial hypertension and admission diagnosis of "resistant hypertension"
• Informed consent
• Kidney function (estimated glomerular filtration rate \[eGFR\] ≥ 45 ml/min/1.73 m2)

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Medical Outpatient Department of the Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for therapeutic drug monitoring

MeSH Terms

Conditions

Hypertension; Hypertension Resistant to Conventional Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jürgen Scholze, Professor

  Charite - Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

• Reinhold Kreutz, Professor

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jürgen Scholze, Professor

CONTACT

juergen.scholze@charite.de

Reinhold Kreutz, Professor

CONTACT

reinhold.kreutz@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Medical Outpatient Department of the Charité - Universitätsmedizin Berlin

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 1, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2016
• Last Updated: February 23, 2015

Record last verified: 2015-02

Locations

DE (1)