Arterial HypertensionNCT03548623
Patient Preference in Blood Pressure Therapy
An observational study of Arterial Hypertension, run by Roland E. Schmieder at 1 site in Germany.
Trial summary
Written surveys of patients with high blood pressure are designed to determine how they would likely decide if, in addition to taking medication, they had another option to treat their hypertension. The alternative treatment option is renal sympathetic denervation using catheter ablation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arterial Hypertension
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2017to 31 Oct 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * male and female * > 18 years
Who may be able to join
- untreated Hypertension
- treated Hypertension with one or more medications
Who cannot join
- illiteracy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Preference in Blood Pressure Therapy: Questioning of Patients With Hypertension
Written surveys of patients with high blood pressure are designed to determine how they would likely decide if, in addition to taking medication, they had another option to treat their hypertension.
The alternative treatment option is renal sympathetic denervation using catheter ablation. This new treatment method is not yet used in the standard care. Currently, studies are being conducted in specific centers to demonstrate the efficacy of this treatment.
Questionnaires are used to determine the preference of patients for one or the other option of hypertension treatment. So far, there are no findings.
- Conditions
- Arterial Hypertension
- Keywords
- Hypertension, renal denervation, preference, shared decision making
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference of treatment
Questionnaires
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start1 May 2017
- Primary completion30 Apr 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roland E. Schmieder
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Preventive Medicine
- Responsible party
- Sponsor-investigator, Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548623
- Sponsor's protocol ID
- CRC2017PPiB
- Status last verified
- Feb 2020
- First submitted
- 23 Apr 2018
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preference in Blood Pressure Therapy: Questioning of Patients With Hypertension
- ClinicalTrials.gov ID
- NCT03548623
- Acronym / sponsor ID
- CRC2017PPiB
- Conditions
- Arterial Hypertension
- Keywords
- Hypertension, renal denervation, preference, shared decision making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Roland E. SchmiederUniversity, hospital or other
- Collaborators
- Institute for Preventive Medicine
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 7 Jun 2018 (actual)
- 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.
Written surveys of patients with high blood pressure are designed to determine how they would likely decide if, in addition to taking medication, they had another option to treat their hypertension.
The alternative treatment option is renal sympathetic denervation using catheter ablation. This new treatment method is not yet used in the standard care. Currently, studies are being conducted in specific centers to demonstrate the efficacy of this treatment.
Questionnaires are used to determine the preference of patients for one or the other option of hypertension treatment. So far, there are no findings.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * male and female * > 18 years
Key inclusion criteria (2 listed)
- untreated Hypertension
- treated Hypertension with one or more medications
Key exclusion criteria (1 listed)
- illiteracy
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
Preference of treatment
Time frame: 3 months
Questionnaires
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Arterial Hypertension
Not yet recruitingPhase 4
An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan and Standard Treatment on Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients Without Hypertensive
Atrial Fibrillation (Persistent), Catheter Ablation
Recruiting
Effects of Balance Training in Individuals With Glaucoma
Glaucoma
RecruitingPhase 4
Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome
Hypertension, Hypercortisolemia
Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
Portal Hypertension Related to Cirrhosis, Ascites
RecruitingPhase 2
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
Pulmonary Arterial Hypertension
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arterial Hypertension, run by Roland E. Schmieder 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 1 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: finished, as of the sponsor's last update on 18 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preference of treatment (time frame: 3 months). 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 18 Feb 2020.