Essential HypertensionNCT00286884
Heart Rate Variability in White Coat Hypertension and Essential Hypertension
An observational study of Essential Hypertension and White Coat Hypertension, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial summary
The aim of the study is to investigate heart rate variability in patients with white coat hypertension and patients with essential hypertension. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension, White Coat Hypertension, Healthy
- What is being tested?
- Monitoring of heart rate variability
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteDenmark
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Medical Research, Holstebro Hospital
Holstebro, 7500
About this study
The aim of the study is to investigate heart rate variability in patients with white coat hypertension and patients with essential hypertension.
- Conditions
- Essential Hypertension, White Coat Hypertension, Healthy
- Being tested
- Monitoring of heart rate variability
- Medical subject headings
- Essential Hypertension, White Coat Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of heart rate variabilityProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 65 participants
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Investigators
- Line B Madsen, MD, Principal investigator, Regional Hospital HolstebroErling B Pedersen, MD, Study chair, Regional Hospital Holstebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286884
- Sponsor's protocol ID
- MED.RES.HOS.2003.01.LBM
- Status last verified
- Sep 2006
- First submitted
- 3 Feb 2006
- Last updated
- 11 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability in White Coat Hypertension and Essential Hypertension
- ClinicalTrials.gov ID
- NCT00286884
- Acronym / sponsor ID
- MED.RES.HOS.2003.01.LBM
- Conditions
- Essential Hypertension, White Coat Hypertension, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- First posted
- 6 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate heart rate variability in patients with white coat hypertension and patients with essential hypertension.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring of heart rate variability | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Line B Madsen, MD principal investigator
Regional Hospital Holstebro
Erling B Pedersen, MD study chair
Regional Hospital Holstebro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Hypertension and White Coat Hypertension, run by Regional Hospital Holstebro at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2006.