HypertensionHOSANCT02078765
Nocturnal Blood Pressure and Hypertension - Central and Peripheral 24-h Blood Pressure.
An observational study of Hypertension and Chronic Kidneys Disease, run by Erling Bjerregaard Pedersen at 1 site in Denmark.
Trial summary
A new study have shown that high night time blood pressure (BP) and/or non-dipping (lack of fall in BP during night time) is a strong predictor for the risk of cardiovascular disease and mortality in patients with hypertension. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Chronic Kidneys Disease, Obstructive Sleep Apnea
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Dec 2017
- 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 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1: 75 patients with hypertension, recruited from another study in the Holstebro Area, contacted by letter. Group 2: healthy subjects are recruited though posters in public and private companies as well as advertising in local media.
Who may be able to join
- Chronic kidney disease (CKD stage I and II), estimated glomerule filtration rate (eGFR) 60-90 ml/min/1.73 m2 or eGFR> 90 ml/min/1.73 m2 and proteinuria or other signs of kidney damage.
- Hypertension (BP by ambulatory or home blood pressure> 135/85 mmHg, or consultation blood pressure> 140/90 mmHg).
- Both men and women
- 55-70 years
- A completed consent form
- Healthy subjects men and women
- age 55 - 70 years
- Body mass index within the normal range, between 18.5 to 25.0 kg/m2
Who cannot join
- Lack of desire to participate
- In the treatment of OSA
- Malignant disease
- Abuse of drugs or alcohol
- Pregnant and breastfeeding
- Incompensated heart failure
Show all 24Show fewer
- Atrial fibrillation
- Liver disease (Alanine aminotransferase (ALT)> 200)
- Severe chronic obstructive pulmonary disease (COPD) (Forced expiratory volume in 1 second <50% predicted)
- eGFR <60 ml/min/1.73 m2
- Blood pressure difference between the right and left arm> 10/10 mmHg
- Group 2 - Healthy subjects
- Arterial hypertension, ambulatory blood pressure> 130 mmHg systolic and / or 80 mmHg diastolic.
- a history or clinical signs of cardial, pulmonary, hepato, renal, endocrine, cerebral or neoplastic disorders
- Alcohol abuse, ie. > 14 drinks / week for women and> 21/uge for men
- Substance abuse
- Medical treatment apart from oral contraceptives
- Smoking
- Pregnancy or breastfeeding
- Lack of desire to participate
- Clinically significant, discrepant results of blood or urine sample at inclusion study (B-hemoglobin and B-White blood cell count, p-sodium, p-potassium, p-creatinine, p-ALT, p-bilirubin , p-Alkaline phosphatase, p-cholesterol, p-albumin or b-glucose and urine for hematuria, albuminuria or glucosuria)
- Clinically significant variations in the electrocardiogram
- Blood Donation for the past month preceding the day on the first attempt sequence
- Blood pressure difference between the right and left arm> 10/10 mmHg.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Medical Research and Medicine, Holstebro Regional Hospital
Holstebro, Holstebro, 7500
About this study
Official title: Nocturnal Blood Pressure in Hypertension, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure
A new study have shown that high night time blood pressure (BP) and/or non-dipping (lack of fall in BP during night time) is a strong predictor for the risk of cardiovascular disease and mortality in patients with hypertension. Three factors seem to affect the night time BP: chronic kidney disease, obstructive sleep apnea (OSA) and the way ambulatory blood pressure is monitored.
Hypothesis:
Read more
Central 24-h blood pressure monitoring is a better way of monitoring blood pressure than conventional peripheral monitoring.
In hypertension, chronic kidney disease and obstructive sleep apnea (OSA) the night time blood pressure is elevated, and is OSA the elevation is correlated to the severity of OSA.
In OSA the kidneys handling of salt and water is disturbed. In OSA there is disturbances in hormonal balance.
Read the detailed description
75 patients with hypertension and chronic kidney disease (CKD I-II) and 75 healthy subjects is examined with both central and peripheral 24 hours blood pressure monitoring, 1 night home polygraphy to determine whether the subject has obstructive sleep apnea (OSA), and if so the degree (apnea hypopnea index, AHI), blood and urine samples to determine levels of urine aquaporine2 (u-AQP2), urine endothelial sodium channel (u-EnaC), plasma renin concentration (PRC), plasma angiotensin II (p-AngII), plasma aldosterone (p-aldosterone), plasma vasopressin (p-AVP) and plasma endothelin (p-endothelin).
Hypothesis:
Central 24-h BP monitoring provides another measure of daily fluctuations in blood pressure than peripheral 24-h BP monitoring, because this measurement is painless and does not interfere with activities in the daytime or night-time sleep.
In hypertension, chronic kidney disease and OSA the decease in nocturnal BP is lower than i healthy subjects.
In OSA the decrease in the nocturnal BP is inversely correlated with the severity of OSA.
In OSA is the renal tubular absorption of water and sodium abnormal with increased tubular absorption of water with AQP2 and of sodium by ENAC.
In OSA, there is increased activity of the renin-angiotensin-aldosterone system, increased endothelin in plasma and increased vasopressin in plasma.
- Keywords
- hypertension, chronic kidneys disease, obstructive sleep apnea, 24-h blood pressure, central blood pressure, peripheral blood pressure
- Medical subject headings
- Hypertension, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hypertension | 75 patients with hypertension and chronic kidney disease (CKD stage I-II) | |
| healthy subjects | 75 healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease in central systolic blood pressure at night
The difference in the decrease in systolic BP at night by peripheral 24-h BP between patients with hypertension and healthy subjects.
Measured: < 24 hours
Secondary outcomes (5)
decrease in central systolic blood pressure at night
The difference in the decrease in systolic BP at night by the central 24-h BP between patients with hypertension and healthy subjects.
Measured: < 24 hours
difference i blood pressure levels throughout the day
The difference in systolic blood pressure and diastolic blood pressure throughout the day, in the daytime and in nighttime between peripheral 24-h and central 24-h monitoring in both patients and healthy.
Measured: < 24 hours
The correlation between the decrease in nighttime BP on one side and severity of OSA and BP in the daytime on the other.
The correlation between the decrease in nighttime BP on one side and severity of OSA and BP in the daytime on the other.
Measured: < 24 hours
u-AQP2 and u-ENac
In 24-h urine samples
Measured: 24 hours
PRC, p-AngII, p-aldosterone, p-AVP, p-endothelin
blood samples
Measured: < 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erling Bjerregaard Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078765
- Sponsor's protocol ID
- BGH-2-2013
- Other IDs
- M-2013-303-13
- Acronym
- HOSA
- Status last verified
- Oct 2014
- First submitted
- 1 Mar 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nocturnal Blood Pressure in Hypertension, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure
- ClinicalTrials.gov ID
- NCT02078765
- Acronym / sponsor ID
- HOSA / BGH-2-2013
- Keywords
- hypertension, chronic kidneys disease, obstructive sleep apnea, 24-h blood pressure, central blood pressure, peripheral blood pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Erling Bjerregaard PedersenUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 5 Mar 2014 (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.
A new study have shown that high night time blood pressure (BP) and/or non-dipping (lack of fall in BP during night time) is a strong predictor for the risk of cardiovascular disease and mortality in patients with hypertension. Three factors seem to affect the night time BP: chronic kidney disease, obstructive sleep apnea (OSA) and the way ambulatory blood pressure is monitored.
Hypothesis:
Central 24-h blood pressure monitoring is a better way of monitoring blood pressure than conventional peripheral monitoring.
In hypertension, chronic kidney disease and obstructive sleep apnea (OSA) the night time blood pressure is elevated, and is OSA the elevation is correlated to the severity of OSA.
In OSA the kidneys handling of salt and water is disturbed. In OSA there is disturbances in hormonal balance.
Detailed description
75 patients with hypertension and chronic kidney disease (CKD I-II) and 75 healthy subjects is examined with both central and peripheral 24 hours blood pressure monitoring, 1 night home polygraphy to determine whether the subject has obstructive sleep apnea (OSA), and if so the degree (apnea hypopnea index, AHI), blood and urine samples to determine levels of urine aquaporine2 (u-AQP2), urine endothelial sodium channel (u-EnaC), plasma renin concentration (PRC), plasma angiotensin II (p-AngII), plasma aldosterone (p-aldosterone), plasma vasopressin (p-AVP) and plasma endothelin (p-endothelin).
Hypothesis:
Central 24-h BP monitoring provides another measure of daily fluctuations in blood pressure than peripheral 24-h BP monitoring, because this measurement is painless and does not interfere with activities in the daytime or night-time sleep.
In hypertension, chronic kidney disease and OSA the decease in nocturnal BP is lower than i healthy subjects.
In OSA the decrease in the nocturnal BP is inversely correlated with the severity of OSA.
In OSA is the renal tubular absorption of water and sodium abnormal with increased tubular absorption of water with AQP2 and of sodium by ENAC.
In OSA, there is increased activity of the renin-angiotensin-aldosterone system, increased endothelin in plasma and increased vasopressin in plasma.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertension | – | –75 patients with hypertension and chronic kidney disease (CKD stage I-II) |
| healthy subjects | – | –75 healthy subjects |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: 75 patients with hypertension, recruited from another study in the Holstebro Area, contacted by letter. Group 2: healthy subjects are recruited though posters in public and private companies as well as advertising in local media.
Key inclusion criteria (8 listed)
- Chronic kidney disease (CKD stage I and II), estimated glomerule filtration rate (eGFR) 60-90 ml/min/1.73 m2 or eGFR> 90 ml/min/1.73 m2 and proteinuria or other signs of kidney damage.
- Hypertension (BP by ambulatory or home blood pressure> 135/85 mmHg, or consultation blood pressure> 140/90 mmHg).
- Both men and women
- 55-70 years
- A completed consent form
Key exclusion criteria (24 listed)
- Lack of desire to participate
- In the treatment of OSA
- Malignant disease
- Abuse of drugs or alcohol
- Pregnant and breastfeeding
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
decrease in central systolic blood pressure at night
Time frame: < 24 hours
The difference in the decrease in systolic BP at night by peripheral 24-h BP between patients with hypertension and healthy subjects.
5 secondary outcomes
decrease in central systolic blood pressure at night
Time frame: < 24 hours
difference i blood pressure levels throughout the day
Time frame: < 24 hours
The correlation between the decrease in nighttime BP on one side and severity of OSA and BP in the daytime on the other.
Time frame: < 24 hours
u-AQP2 and u-ENac
Time frame: 24 hours
PRC, p-AngII, p-aldosterone, p-AVP, p-endothelin
Time frame: < 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypertension and Chronic Kidneys Disease, run by Erling Bjerregaard Pedersen 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 8 inclusion and 24 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 9 Oct 2014. 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?
Results are not available in the source record.
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.
What does the primary outcome measure?
decrease in central systolic blood pressure at night (time frame: < 24 hours). It is what the study was designed to measure, not a finding.
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 9 Oct 2014.