NCT00139984

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Oct 2003

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

First QC Date

August 29, 2005

Last Update Submit

February 1, 2017

Conditions

Hypertension

Keywords

HypertensionAmbulatory blood pressure monitoringBlood pressureRisk assessment

Outcome Measures

Primary Outcomes (1)

  • Change in 24-hour systolic blood pressure from baseline to 1 year

Secondary Outcomes (2)

  • Change in 24-hour diastolic blood pressure from baseline to 1 year

  • Primary outcome measure in patients with treated hypertension at baseline

Interventions

24 hour blood pressure measurementDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical Outpatient Clinic, University Hospital Basel

Basel, 4031, Switzerland

Location

Private Practice

Basel, 4057, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 18754021DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Blood Pressure Determination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisPhysical Examination

Study Officials

  • David Conen, MD

    Cardiology, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

October 1, 2003

Study Completion

May 1, 2007

Last Updated

February 2, 2017

Record last verified: 2017-02

Locations

CH(2)