Hypertensive DiseaseNCT02128386
Medication Adherence and "True" Resistance in Patients With Resistant Hypertension
An observational study of Hypertensive Disease and Hypertension, Resistant to Conventional Therapy, run by Charite University, Berlin, Germany at 1 site in Germany.
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". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertensive Disease, Hypertension, Resistant to Conventional Therapy
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult male or female patients referred to the Medical Outpatient Department of the Charité - Universitätsmedizin Berlin with the diagnosis "Resistant hypertension".
Who may be able to join
- Female or male adult patients with arterial hypertension and admission diagnosis of "resistant hypertension"
- Informed consent
Who cannot join
- Kidney function (estimated glomerular filtration rate [eGFR] ≥ 45 ml/min/1.73 m2)
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Jürgen Scholze, Professor contact
Reinhold Kreutz, Professor contact
Germany1 site, 1 recruiting
- Recruiting
Medical Outpatient Department of the Charité - Universitätsmedizin Berlin
Berlin, 10117
About this study
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".
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.
- Medical subject headings
- Hypertension, Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: Week 6
Secondary outcomes (4)
Assessment of all costs of both treatments within one year.
Measured: 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.
Measured: 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.
Measured: Week 6 - week 24
Assessment of adverse events in order to evaluate the safety of both treatments.
Measured: During the whole course of the study (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive DiseaseStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Jürgen Scholze, Charite University, Berlin, Germany
- Investigators
- Jürgen Scholze, Professor, Principal investigator, Charite - Universitätsmedizin BerlinReinhold Kreutz, Professor, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128386
- Sponsor's protocol ID
- EA1/328/13
- Status last verified
- Feb 2015
- First submitted
- 29 Apr 2014
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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".
- ClinicalTrials.gov ID
- NCT02128386
- Acronym / sponsor ID
- EA1/328/13
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male or female patients referred to the Medical Outpatient Department of the Charité - Universitätsmedizin Berlin with the diagnosis "Resistant hypertension".
Key inclusion criteria (2 listed)
- Female or male adult patients with arterial hypertension and admission diagnosis of "resistant hypertension"
- Informed consent
Key exclusion criteria (11 listed)
- Kidney function (estimated glomerular filtration rate [eGFR] ≥ 45 ml/min/1.73 m2)
- Age < 18 years
- Secondary arterial hypertension
- Type 1 Diabetes mellitus
- Unstable coronary heart disease, myocardial infarction or stroke in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
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
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
Assessment of adverse events in order to evaluate the safety of both treatments.
Time frame: During the whole course of the study (24 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Scholze, Professor contact
Reinhold Kreutz, Professor contact
Jürgen Scholze, Professor principal investigator
Charite - Universitätsmedizin Berlin
Reinhold Kreutz, Professor principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Disease and Hypertension, Resistant to Conventional Therapy, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jürgen Scholze, Professor (juergen.scholze@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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" (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015; AzTrials last refreshed its copy on 7 Nov 2026.