Patient Preference in Blood Pressure Therapy | NCT03548623

Studies
Patient Preference in Blood Pressure Therapy

NCT03548623

Sponsor

Roland E. Schmieder

Status

Completed

Last Update Posted

Feb 18, 2020Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Arterial Hypertension

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2017Actual

Primary Completion Date

Apr 30, 2018Actual

Completion Date

Oct 31, 2018Actual

First Submitted Date

Apr 23, 2018

First Submission Date that Met QC Criteria

Jun 6, 2018

First Posted Date

Jun 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2020

Last Update Posted Date

Feb 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Roland E. Schmieder, Full Professor of Medicine, University of Erlangen-Nürnberg Medical SchoolSponsor-Investigator

Lead Sponsor

Roland E. SchmiederOTHER

Collaborators

Name	Class
Institute for Preventive Medicine	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Preference of treatment	Questionnaires	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

untreated Hypertension
treated Hypertension with one or more medications

Exclusion Criteria:

illiteracy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

male and female
> 18 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute for Preventive Medicine		Nuremberg		90471	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided