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Nocturnal Blood Pressure and Hypertension - Central and Peripheral 24-h Blood Pressure. (HOSA)

8 de outubro de 2014 atualizado por: Erling Bjerregaard Pedersen

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:

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.

Visão geral do estudo

Status

Desconhecido

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Antecipado)

150

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Dinamarca
- - Holstebro, Dinamarca, 7500
    - Department of Medical Research and Medicine, Holstebro Regional Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

55 anos a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
hypertension 75 patients with hypertension and chronic kidney disease (CKD stage I-II)
healthy subjects 75 healthy subjects

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
decrease in central systolic blood pressure at night Prazo: < 24 hours	The difference in the decrease in systolic BP at night by peripheral 24-h BP between patients with hypertension and healthy subjects.	< 24 hours

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
decrease in central systolic blood pressure at night Prazo: < 24 hours	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
difference i blood pressure levels throughout the day Prazo: < 24 hours	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
The correlation between the decrease in nighttime BP on one side and severity of OSA and BP in the daytime on the other. Prazo: < 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 Prazo: 24 hours	In 24-h urine samples	24 hours
PRC, p-AngII, p-aldosterone, p-AVP, p-endothelin Prazo: < 1 hour	blood samples	< 1 hour

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Erling Bjerregaard Pedersen

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2014

Conclusão Primária (Antecipado)

1 de dezembro de 2015

Conclusão do estudo (Antecipado)

1 de dezembro de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

1 de março de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ