Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02128386
Recruitment Status : Unknown
Verified February 2015 by Prof. Jürgen Scholze, Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : May 1, 2014
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Prof. Jürgen Scholze, Charite University, Berlin, Germany

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.

Condition or disease
Hypertensive Disease Hypertension, Resistant to Conventional Therapy

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : February 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  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" [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Assessment of all costs of both treatments within one year. [ Time Frame: During the whole course of the study (24 weeks) and for another 24 weeks after the end of the study ]
  2. 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. [ Time Frame: Baseline, week 6, end of study on week 24 ]
  3. 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. [ Time Frame: Week 6 - week 24 ]
  4. Assessment of adverse events in order to evaluate the safety of both treatments. [ Time Frame: During the whole course of the study (24 weeks) ]

Biospecimen Retention:   Samples Without DNA
Blood samples for therapeutic drug monitoring


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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".
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128386


Contacts
Layout table for location contacts
Contact: Jürgen Scholze, Professor juergen.scholze@charite.de
Contact: Reinhold Kreutz, Professor reinhold.kreutz@charite.de

Locations
Layout table for location information
Germany
Medical Outpatient Department of the Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Layout table for investigator information
Principal Investigator: Jürgen Scholze, Professor Charite - Universitätsmedizin Berlin
Principal Investigator: Reinhold Kreutz, Professor Charite University, Berlin, Germany

Layout table for additonal information
Responsible Party: Prof. Jürgen Scholze, Head of the Medical Outpatient Department of the Charité - Universitätsmedizin Berlin, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02128386     History of Changes
Other Study ID Numbers: EA1/328/13
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Coronary Vasospasm
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action