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Patient Preference in Blood Pressure Therapy

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: NCT03548623
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
Institute for Preventive Medicine
Information provided by (Responsible Party):
Roland E. Schmieder, University of Erlangen-Nürnberg Medical School

Tracking Information
First Submitted Date April 23, 2018
First Posted Date June 7, 2018
Last Update Posted Date February 18, 2020
Actual Study Start Date May 1, 2017
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2018)
Preference of treatment [ Time Frame: 3 months ]
Questionnaires
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Patient Preference in Blood Pressure Therapy
Official Title Patient Preference in Blood Pressure Therapy: Questioning of Patients With Hypertension
Brief 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. 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population
  • male and female
  • > 18 years
Condition Arterial Hypertension
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 6, 2018)
1000
Original Actual Enrollment Same as current
Actual Study Completion Date October 31, 2018
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • untreated Hypertension
  • treated Hypertension with one or more medications

Exclusion Criteria:

  • illiteracy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03548623
Other Study ID Numbers CRC2017PPiB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
Study Sponsor Roland E. Schmieder
Collaborators Institute for Preventive Medicine
Investigators Not Provided
PRS Account University of Erlangen-Nürnberg Medical School
Verification Date February 2020