Ambulatory Blood Pressure Monitoring for Antihypertensive... | NCT00139984

Studies
Ambulatory Blood Pressure Monitoring for Antihypertensive Treatment Guidance

NCT00139984

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Feb 2, 2017Estimated

Enrollment

170Estimated

Phase

Phase 4

Conditions

Hypertension

Interventions

24 hour blood pressure measurement

Countries

Switzerland

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 2017

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

Oct 2003

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

Aug 29, 2005

First Submission Date that Met QC Criteria

Aug 29, 2005

First Posted Date

Aug 31, 2005Estimated

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 1, 2017

Last Update Posted Date

Feb 2, 2017Estimated

Name	Class
Bayer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to determine whether in patients with arterial hypertension, treatment guidance using 24-hour blood pressure measurement results in better blood pressure control compared to treatment guidance using office blood pressure measurement.

Detailed Description

Blood pressure control in arterial hypertension remains poor, despite the availability of effective drug treatment. Therefore, strategies to increase blood pressure control are urgently needed. 24 hour blood pressure is a better predictor of cardiovascular morbidity and mortality than office blood pressure. Furthermore, the lower variability of measurements over time of 24 hour blood pressure could allow better adjustment of antihypertensive therapy. However, there are only scarce data about antihypertensive treatment adjustment using 24 hour blood pressure instead of office blood pressure.

Aim: To test the hypothesis that a 24 hour blood pressure guided therapy is is more effective in reaching blood pressure control when compared to conventional office blood pressure guided therapy.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

170Estimated

Name	Type	Description	Arm Group Labels	Other Names
24 hour blood pressure measurement	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in 24-hour systolic blood pressure from baseline to 1 year

Secondary Outcomes

Measure	Description	Time Frame
Change in 24-hour diastolic blood pressure from baseline to 1 year
Primary outcome measure in patients with treated hypertension at baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Uncontrolled hypertension (office BP >139/89mmHg AND 24h BP >129/79mmHg)

Exclusion Criteria:

Severe concomitant illness including heart failure, significant valvular heart disease or malignancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Conen, MD	Cardiology, University Hospital Basel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Outpatient Clinic, University Hospital Basel		Basel		4031	Switzerland
Private Practice

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18754021	Derived	Conen D, Tschudi P, Martina B. Twenty-four hour ambulatory blood pressure for the management of antihypertensive treatment: a randomized controlled trial. J Hum Hypertens. 2009 Feb;23(2):122-9. doi: 10.1038/jhh.2008.106. Epub 2008 Aug 28.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D010808	Physical Examination