Nocturnal Blood Pressure and Hypertension - Central and Peripheral 24-h Blood Pressure.

Hypertension Clinical Trial

— HOSA  

Official title:

Nocturnal Blood Pressure in Hypertension, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02078765
• Other study ID #: BGH-2-2013
• Secondary ID: M-2013-303-13
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 1, 2014
• Last updated: October 8, 2014
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: October 2014
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 70 Years

Eligibility

Group 1:

Inclusion Criteria:

• 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

Exclusion Criteria:

• Lack of desire to participate

• In the treatment of OSA

• Malignant disease

• Abuse of drugs or alcohol

• Pregnant and breastfeeding

• Incompensated heart failure

• 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

Inclusion Criteria:

• Healthy subjects men and women

• age 55 - 70 years

• Body mass index within the normal range, between 18.5 to 25.0 kg/m2

Exclusion Criteria:

• 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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Kidneys Disease
• Hypertension
• Kidney Diseases
• Obstructive Sleep Apnea
• Renal Insufficiency, Chronic
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Denmark	Department of Medical Research and Medicine, Holstebro Regional Hospital	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Erling Bjerregaard Pedersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	< 24 hours	No
Secondary	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.	< 24 hours	No
Secondary	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.	< 24 hours	No
Secondary	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.	< 24 hours	No
Secondary	u-AQP2 and u-ENac	In 24-h urine samples	24 hours	No
Secondary	PRC, p-AngII, p-aldosterone, p-AVP, p-endothelin	blood samples	< 1 hour	No