Chronic Kidney DiseaseNOSANCT01951196
Nocturnal Blood Pressure - Central and Peripheral 24-h Blood Pressure in Chronic Kidney Disease.
An observational study of Chronic Kidney Disease and Obstructive Sleep Apnea, run by Erling Bjerregaard Pedersen at 1 site in Denmark.
Trial summary
A new study have shown that high nighttime blood pressure (BP) and/or non-dipping (lack of fall in blood pressure during nighttime) 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 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Obstructive Sleep Apnea
- Type of treatment
- Injection or infusion
- How many people
- 225 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Oct 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1: Patients with chronic kidney disease, CKD stage III-IV. The patients is followed for their kidney disease at Holstebro Regional Hospital, Denmark, Medical clinic, and the are chosen to participate in the study because of this relation. Group 2: Healthy subjects. They arerecruited through postings on public and private companies as well as advertising in local medier.
Who may be able to join
- eGFR 15-59 mL/min/1.73 m2 (estimated GFR)
- 18-80 years
- males and females
- Healthy volunteers men and women
- age 40 - 80 years
- BMI within the normal range, ie. between 18.5 to 25.0 kg/m2
Who cannot join
- lack of desire to participate
- treatment for OSA
- malignant disease
- Abuse of drugs or alcohol
- pregnant and lactating
- incompensated heart failure
Show all 21Show fewer
- atrial fibrillation
- liver disease (ALAT> 200)
- Severe chronic obstructive lung disease (forced expiratory volume in 1 second <50% predicted)
- Healthy Subjects:
- Arterial hypertension, ie. 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
- Daily medicine intake/ 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 (ie B-hemoglobin and B-White blood cell count, p-Sodium, p-Potassium, p-creatinine, p-ALAT, p-bilirubin , p-alkaline phosphatase, p-cholesterol, p-albumin or b-glucose and urine for hematuria, albuminuria or glucosuria)
- Clinically significant differences in the electrocardiogram
- Blood Donation for the past month preceding the day on the first attempt sequence.
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 Chronic Kidney Disease, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure.
A new study have shown that high nighttime blood pressure (BP) and/or non-dipping (lack of fall in blood pressure during nighttime) is a strong predictor for the risk of cardiovascular disease and mortality in patients with hypertension. Three factors seem to affect the night time blood pressure: chronic kidney disease, obstructive sleep apnea (OSA) or the way ambulatory blood pressure is monitored.
The aim of this study is to analyse the importance of these three factors on nighttime bloodpressure.
Read more
Hypothesis:
Central 24 hour blood pressure monitoring provides another measure of daily fluctuations in blood pressure than peripheral 24 hour blood pressure monitoring, because measurement is painless and does not interfere with activities during the daytime or night-time sleep
In chronic kidney disease and OSA the decrease in nocturnal BP is lower than in healthy subjects.
In chronic kidney disease the decrease in the nocturnal BP is inversely correlated to the severity of OSA, the severity of kidney disease, and blood pressure during daytime.
Read the detailed description
150 patients with chronic kidney disease (CKD III-IV) and 75 healthy subject 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, and if so the degree (AHI), blood- and urine samples to determine levels of u-AQP2 og u-ENaCɣ, PRC, p-AngII, p-Aldosterone, p-Avp og p-Endothelin.
- Conditions
- Chronic Kidney Disease, Obstructive Sleep Apnea
- Keywords
- Chronic kidney disease, 24 hour blood pressure, central blood pressure, peripheral blood pressure, obstructive sleep apnea
- Medical subject headings
- Renal Insufficiency, Chronic, 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 |
|---|---|---|
| Chronic kidney disease, CKD III+IV | 150 patients with Chronic kidney disease, CKD stage III+IV. | |
| Healthy subjects | 75 healthy subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease in peripheral systolic blood pressure at night
The difference in the decrease in systolic blood pressure at night by peripheral 24-h BP between patients with chronic kidney disease 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 central 24-h BP between patients with chronic kidney disease and healthy subjects.
Measured: < 24 hours
difference in peripheral and central systolic and diastolic blood pressure throughout the day, during the daytime and during nighttime
The difference in systolic blood pressure and diastolic blood pressure throughout the day, during the daytime and during nighttime between measurements with peripheral 24-hour monitoring and central 24 hour monitoring in both patients with chronic kidney disease and healthy subjects.
Measured: < 24 hours
The correlation between the decrease in nighttime blood pressure on the one hand and severity of OSA, severity of kidney disease and blood pressure during the daytime on the other.
Measured: < 24 hours
U-AQP2 (urine aquaporin 2) og u-ENaCɣ (urine epithelial sodium channel)
24 hour urine sample.
Measured: 24 hours
PRC (plasma renin concentration), p-AngII (angiotensin II), p-Aldosterone. P-Avp (vasopressin), p-Endothelin.
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 posted26 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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
- 225 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
- NCT01951196
- Sponsor's protocol ID
- BGH-1-2013
- Other IDs
- M-2013-224-13
- Acronym
- NOSA
- Status last verified
- Oct 2014
- First submitted
- 23 Sep 2013
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hornstrup BG, Gjoerup PH, Wessels J, Lauridsen TG, Pedersen EB, Bech JN. Nocturnal blood pressure decrease in patients with chronic kidney disease and in healthy controls - significance of obstructive sleep apnea and renal function. Int J Nephrol Renovasc Dis. 2018 Nov 8;11:279-290. doi: 10.2147/IJNRD.S176606. eCollection 2018.
PubMed 30510439
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 Chronic Kidney Disease, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure.
- ClinicalTrials.gov ID
- NCT01951196
- Acronym / sponsor ID
- NOSA / BGH-1-2013
- Conditions
- Chronic Kidney Disease, Obstructive Sleep Apnea
- Keywords
- Chronic kidney disease, 24 hour blood pressure, central blood pressure, peripheral blood pressure, obstructive sleep apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Erling Bjerregaard PedersenUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 26 Sep 2013 (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 nighttime blood pressure (BP) and/or non-dipping (lack of fall in blood pressure during nighttime) is a strong predictor for the risk of cardiovascular disease and mortality in patients with hypertension. Three factors seem to affect the night time blood pressure: chronic kidney disease, obstructive sleep apnea (OSA) or the way ambulatory blood pressure is monitored.
The aim of this study is to analyse the importance of these three factors on nighttime bloodpressure.
Hypothesis:
Central 24 hour blood pressure monitoring provides another measure of daily fluctuations in blood pressure than peripheral 24 hour blood pressure monitoring, because measurement is painless and does not interfere with activities during the daytime or night-time sleep
In chronic kidney disease and OSA the decrease in nocturnal BP is lower than in healthy subjects.
In chronic kidney disease the decrease in the nocturnal BP is inversely correlated to the severity of OSA, the severity of kidney disease, and blood pressure during daytime.
Detailed description
150 patients with chronic kidney disease (CKD III-IV) and 75 healthy subject 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, and if so the degree (AHI), blood- and urine samples to determine levels of u-AQP2 og u-ENaCɣ, PRC, p-AngII, p-Aldosterone, p-Avp og p-Endothelin.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease, CKD III+IV | – | –150 patients with Chronic kidney disease, CKD stage III+IV. |
| Healthy subjects | – | –75 healthy subjects. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: Patients with chronic kidney disease, CKD stage III-IV. The patients is followed for their kidney disease at Holstebro Regional Hospital, Denmark, Medical clinic, and the are chosen to participate in the study because of this relation. Group 2: Healthy subjects. They arerecruited through postings on public and private companies as well as advertising in local medier.
Key inclusion criteria (6 listed)
- eGFR 15-59 mL/min/1.73 m2 (estimated GFR)
- 18-80 years
- males and females
- Healthy volunteers men and women
- age 40 - 80 years
Key exclusion criteria (21 listed)
- lack of desire to participate
- treatment for OSA
- malignant disease
- Abuse of drugs or alcohol
- pregnant and lactating
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 peripheral systolic blood pressure at night
Time frame: < 24 hours
The difference in the decrease in systolic blood pressure at night by peripheral 24-h BP between patients with chronic kidney disease and healthy subjects.
5 secondary outcomes
decrease in central systolic blood pressure at night
Time frame: < 24 hours
difference in peripheral and central systolic and diastolic blood pressure throughout the day, during the daytime and during nighttime
Time frame: < 24 hours
The correlation between the decrease in nighttime blood pressure on the one hand and severity of OSA, severity of kidney disease and blood pressure during the daytime on the other.
Time frame: < 24 hours
U-AQP2 (urine aquaporin 2) og u-ENaCɣ (urine epithelial sodium channel)
Time frame: 24 hours
PRC (plasma renin concentration), p-AngII (angiotensin II), p-Aldosterone. P-Avp (vasopressin), 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.
- Derived from this study: PubMed 30510439Hornstrup BG, Gjoerup PH, Wessels J, Lauridsen TG, Pedersen EB, Bech JN. Nocturnal blood pressure decrease in patients with chronic kidney disease and in healthy controls - significance of obstructive sleep apnea and renal function. Int J Nephrol Renovasc Dis. 2018 Nov 8;11:279-290. doi: 10.2147/IJNRD.S176606. eCollection 2018.
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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 Chronic Kidney Disease and Obstructive Sleep Apnea, 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 6 inclusion and 21 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 peripheral 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?
On the ClinicalTrials.gov record for NCT01951196, which also lists 1 linked publication.
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.