Nocturnal HypertensionNCT01533584
Evaluation of Nocturnal Hypertension and Correlation With Target-Organ Damage
An observational study of Nocturnal Hypertension, run by University of Athens at 2 sites in Greece.
Trial summary
The aim of this study is to evaluate nocturnal hypertension with 24-hour ambulatory blood pressure and home blood pressure (BP) measurements through a) comparison of mean BP and nocturnal dipping assessed with the two methods, b) correlation of those parameters with parameters of target-organ damage and c) comparison… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Nocturnal Hypertension
- How many people
- 100 participants
- Where
- 2 sitesGreece
- Study dates
- Mar 2012to Feb 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects referred for high Blood Pressure, untreated or, if treated for less than 2 weeks, 4 weeks after withdrwal of treatment.
Who may be able to join
- Mean 24-hour Systolic BP (SBP) >130 mmHg and/or Mean 24-hour Diastolic BP (DBP) >80 mmHg.
- Patients physically and mentally capable of self-measuring BP at home.
- Written informed consent.
Who cannot join
- Sustained arrhythmia.
- Pregnancy.
- Symptomatic cardiovascular disease.
- Any other serious illness (cardiac, renal, or malignancy).
Trial locations and contacts
2 sites in 1 country.
Greece2 sites, 2 recruiting
- Recruiting
Hypertension Clinic, 3rd Dept. of Medicine, Evaggelismos Hospital.
Athens, 10676
Emmanuel A Andreadis, NHS Director, 00302132045149, andreadise@ath.forthnet.gr
Emmanuel A Andreadis, NHS Director
- Recruiting
Hypertension Center, Third Department of Medicine, University of Athens, Greece
Athens, 11527
George S Stergiou, MD, +302107763117, gstergi@med.uoa.gr
George S Stergiou, MD
About this study
Official title: Evaluation of Nocturnal Hypertension With 24-hour Ambulatory or Home Blood Pressure Measurement: Correlation With Target-Organ Damage
The aim of this study is to evaluate nocturnal hypertension with 24-hour ambulatory blood pressure and home blood pressure (BP) measurements through a) comparison of mean BP and nocturnal dipping assessed with the two methods, b) correlation of those parameters with parameters of target-organ damage and c) comparison of the potential of the two methods to define non-dippers.
Read the detailed description
It is well known that blood pressure (BP) exhibits diurnal variation. Nocturnal fall of BP normally exceeds 10%. Subjects with such fall of BP during sleep are classified as "dippers" and those with a nocturnal fall of BP less than 10% are classified as "non-dippers". Non-dippers are exposed to a greater cardiovascular risk. To date dipping status is defined with 24-hour ambulatory BP monitoring (ABPM). Many studies have shown that Home BP monitoring (HBPM) can be an alternative to daytime ambulatory BP monitoring and it exhibits similar correlation to markers of hypertension target-organ-damage (TOD). Nocturnal hypertension shows closer correlation with TOD, than daytime hypertension. In this study patients will be provided with a new-technology, reliable oscillometric device for HBPM, equipped with a modified algorithm, which allows scheduled automated BP measurements during sleep (Microlife WatchBP Home Nocturnal). Duplicate morning and evening BP measurements with one-minute interval will be performed by the patient sitting during seven working days. Afterwards a 24-hour ABPM will be performed, using Microlife WatchBP O3 oscillometric device, with a 20-minute interval between measurements. This order may be reversed according to the wish of the patient and devices' availability. Participants will visit site 3 times. Office blood pressure will be measured during two visits. Triplicate measurements with Microlife WatchBP Home Nocturnal will be performed at the sitting position.
TOD will be assessed with:
- cardiac triplex (LVMI)
- carotid triplex (ΙΜΤ)
- pulse wave velocity.
- Albumin/creatinine ratio measured in morning urine sample.
- Conditions
- Nocturnal Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George S. Stergiou, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533584
- Sponsor's protocol ID
- NOCTURNAL TOD
- Status last verified
- Sep 2012
- First submitted
- 9 Feb 2012
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nocturnal Hypertension With 24-hour Ambulatory or Home Blood Pressure Measurement: Correlation With Target-Organ Damage
- ClinicalTrials.gov ID
- NCT01533584
- Acronym / sponsor ID
- NOCTURNAL TOD
- Conditions
- Nocturnal Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 15 Feb 2012 (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 this study is to evaluate nocturnal hypertension with 24-hour ambulatory blood pressure and home blood pressure (BP) measurements through a) comparison of mean BP and nocturnal dipping assessed with the two methods, b) correlation of those parameters with parameters of target-organ damage and c) comparison of the potential of the two methods to define non-dippers.
Detailed description
It is well known that blood pressure (BP) exhibits diurnal variation. Nocturnal fall of BP normally exceeds 10%. Subjects with such fall of BP during sleep are classified as "dippers" and those with a nocturnal fall of BP less than 10% are classified as "non-dippers". Non-dippers are exposed to a greater cardiovascular risk. To date dipping status is defined with 24-hour ambulatory BP monitoring (ABPM). Many studies have shown that Home BP monitoring (HBPM) can be an alternative to daytime ambulatory BP monitoring and it exhibits similar correlation to markers of hypertension target-organ-damage (TOD). Nocturnal hypertension shows closer correlation with TOD, than daytime hypertension. In this study patients will be provided with a new-technology, reliable oscillometric device for HBPM, equipped with a modified algorithm, which allows scheduled automated BP measurements during sleep (Microlife WatchBP Home Nocturnal). Duplicate morning and evening BP measurements with one-minute interval will be performed by the patient sitting during seven working days. Afterwards a 24-hour ABPM will be performed, using Microlife WatchBP O3 oscillometric device, with a 20-minute interval between measurements. This order may be reversed according to the wish of the patient and devices' availability. Participants will visit site 3 times. Office blood pressure will be measured during two visits. Triplicate measurements with Microlife WatchBP Home Nocturnal will be performed at the sitting position.
TOD will be assessed with:
- cardiac triplex (LVMI)
- carotid triplex (ΙΜΤ)
- pulse wave velocity.
- Albumin/creatinine ratio measured in morning urine sample.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred for high Blood Pressure, untreated or, if treated for less than 2 weeks, 4 weeks after withdrwal of treatment.
Key inclusion criteria (3 listed)
- Mean 24-hour Systolic BP (SBP) >130 mmHg and/or Mean 24-hour Diastolic BP (DBP) >80 mmHg.
- Patients physically and mentally capable of self-measuring BP at home.
- Written informed consent.
Key exclusion criteria (4 listed)
- Sustained arrhythmia.
- Pregnancy.
- Symptomatic cardiovascular disease.
- Any other serious illness (cardiac, renal, or malignancy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
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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.
Hypertension Clinic, 3rd Dept. of Medicine, Evaggelismos Hospital.
Athens, Greece
Hypertension Center, Third Department of Medicine, University of Athens, Greece
Athens, Greece
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nocturnal Hypertension, run by University of Athens at 2 sites in Greece.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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 2012.