Heart Rate Variability in White Coat Hypertension and Ess... | NCT00286884

Studies
Heart Rate Variability in White Coat Hypertension and Essential Hypertension

NCT00286884

Sponsor

Regional Hospital Holstebro

Status

Completed

Last Update Posted

Sep 11, 2006Estimated

Enrollment

Phase

Not provided

Conditions

Essential Hypertension
White Coat Hypertension
Healthy

Interventions

Monitoring of heart rate variability

Countries

Denmark

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

Sep 2006

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 3, 2006

First Submission Date that Met QC Criteria

Feb 3, 2006

First Posted Date

Feb 6, 2006Estimated

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

Sep 8, 2006

Last Update Posted Date

Sep 11, 2006Estimated

Description Module

Brief Summary

The aim of the study is to investigate heart rate variability in patients with white coat hypertension and patients with essential hypertension.

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

Not provided

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

Name	Type	Description	Arm Group Labels	Other Names
Monitoring of heart rate variability	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 30-70 years
office BP >150/95 mmHg and 24-h ambulatory BP =/>135/85 mmHg
office BP >150/95 mmHg and 24-h ambulatory BP <135/85 mmHg
office BP <150/95 mmHg and 24-h ambulatory BP <135/85 mmHg

Exclusion Criteria:

Clinical signs of disease of the heart, lungs, liver, kidneys, brain or endocrine organs
neoplastic disease
daily use of medicine
alcohol abuse
abnormal laboratory screening including blood-hemoglobin, blood-white cell count, plasma-creatinine, plasma-alanine-amino-transaminases, plasma-albumin, plasma-sodium, plasma-potassium, urinary glucose, urinary albumin; electrocardiogram
pregnancy
unwillingness to participate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Line B Madsen, MD	Regional Hospital Holstebro	Principal Investigator
Erling B Pedersen, MD	Regional Hospital Holstebro	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medical Research, Holstebro Hospital		Holstebro		7500	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000075222	Essential Hypertension
D059466	White Coat Hypertension

Ancestor Terms

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided