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

NCT02078765 | Unknown

• 2 other identifiers: BGH-2-2013M-2013-303-13
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Chronic Kidneys Disease; Obstructive Sleep Apnea

Keywords

hypertension; chronic kidneys disease; obstructive sleep apnea; 24-h blood pressure; central blood pressure; peripheral blood pressure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• decrease in central systolic blood pressure at night

  < 24 hours

• difference i blood pressure levels throughout the day

  < 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.

  < 24 hours

• u-AQP2 and u-ENac

  24 hours

• PRC, p-AngII, p-aldosterone, p-AVP, p-endothelin

  < 1 hour

Study Arms (2)

hypertension

75 patients with hypertension and chronic kidney disease (CKD stage I-II)

healthy subjects

75 healthy subjects

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• years
• A completed consent form

You may not qualify if:

• 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
• Healthy subjects men and women
• age 55 - 70 years
• Body mass index within the normal range, between 18.5 to 25.0 kg/m2

Sponsors & Collaborators

• Erling Bjerregaard Pedersen: lead

Study Sites (1)

Department of Medical Research and Medicine, Holstebro Regional Hospital

Holstebro, Holstebro, 7500, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum, urine

MeSH Terms

Conditions

Hypertension; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 1, 2014
• First Posted: March 5, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2017
• Last Updated: October 9, 2014

Record last verified: 2014-10

Locations

DK (1)