Nocturnal Blood Pressure - Central and Peripheral 24-h Blood Pressure in Chronic Kidney Disease. (NOSA)
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.
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Holstebro, Dinamarca, 7500
- Department of Medical Research and Medicine, Holstebro Regional Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
Patients, group 1:
Inclusion Criteria:
- eGFR 15-59 mL/min/1.73 m2 (estimated GFR)
- 18-80 years
- males and females
Exclusion Criteria:
- lack of desire to participate
- treatment for OSA
- malignant disease
- Abuse of drugs or alcohol
- pregnant and lactating
- incompensated heart failure
- atrial fibrillation
- liver disease (ALAT> 200)
- Severe chronic obstructive lung disease (forced expiratory volume in 1 second <50% predicted)
Healthy Subjects:
inclusion criteria
- Healthy volunteers men and women
- age 40 - 80 years
- BMI within the normal range, ie. between 18.5 to 25.0 kg/m2
exclusion Criteria
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Chronic kidney disease, CKD III+IV
150 patients with Chronic kidney disease, CKD stage III+IV.
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Healthy subjects
75 healthy subjects.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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decrease in peripheral systolic blood pressure at night
Periodo de tiempo: < 24 hours
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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.
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< 24 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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decrease in central systolic blood pressure at night
Periodo de tiempo: < 24 hours
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The difference in the decrease in systolic BP at night by central 24-h BP between patients with chronic kidney disease and healthy subjects.
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< 24 hours
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difference in peripheral and central systolic and diastolic blood pressure throughout the day, during the daytime and during nighttime
Periodo de tiempo: < 24 hours
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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.
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< 24 hours
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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.
Periodo de tiempo: < 24 hours
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< 24 hours
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U-AQP2 (urine aquaporin 2) og u-ENaCɣ (urine epithelial sodium channel)
Periodo de tiempo: 24 hours
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24 hour urine sample.
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24 hours
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PRC (plasma renin concentration), p-AngII (angiotensin II), p-Aldosterone. P-Avp (vasopressin), p-Endothelin.
Periodo de tiempo: < 1 hour
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< 1 hour
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Trastornos del Sueño Intrínsecos
- Disomnias
- Trastornos del sueño y la vigilia
- Enfermedades urológicas
- Insuficiencia renal
- Signos y Síntomas Respiratorios
- Síndromes de apnea del sueño
- Apnea del Sueño Obstructiva
- Enfermedades Renales
- Insuficiencia Renal Crónica
- Apnea
Otros números de identificación del estudio
- BGH-1-2013
- M-2013-224-13 (Otro identificador: The Regional Committee of Health Research Ethics)
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