Home Versus Ambulatory Monitoring, Diurnal Blood Pressure Profile, Detection of Non-Dippers
Home Versus Ambulatory Monitoring in the Assessment of the Diurnal Blood Pressure Profile and the Detection of Non-Dippers
This is a cross-sectional study, including adults, either untreated for hypertension, or under stable treatment for more than four weeks. Assessment will include:
Clinic blood pressure measurements with an automated oscillometric device, 24-hour ambulatory blood pressure monitoring Home blood pressure monitoring during morning, evening and nocturnal measurements with the same device.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Eligible patients, as described in Inclusion/Exclusion Criteria, will be instructed to use Microlife WatchBP Home-Nocturnal oscillometric device, in order to measure their BP two times with one-minute interval, in the morning between 6 and 9 am and in the evening between 6 and 9 pm respectively for six days. These six days shall be normal working days, selected be the patient, within a time-frame of two weeks approximately. Patients should be sitting for at least five minutes and calm. During three out of those six days, they will apply and activate the same device, in order to take BP measurements while they will be asleep. Those measurements are going to be taken automatically by the device, the first 2-hours after the activation and another two with one-hour interval. Measurements will be averaged as awake and asleep BP values, with a potential to derive, if so wished, separate averages of awake-morning and awake-evening BP values.
Microlife WatchBP O3 Ambulatory Blood Pressure Measurement (ABPM) device will be applied by a doctor to each patient and it will be removed the next day by a doctor. BP measurements will be performed every 20 minutes for 24 hours. BP measurements taken during awake and asleep hours for each patient, will be analyzed separately.
Additionally, triplicate sitting Clinic Blood Pressure measurements, with one-minute interval, will be performed with the Microlife WatchBP Home-Nocturnal device during each patient's visit at the Hypertension Center. Patients will visit Hypertension Center three times, one to apply the ABPM device and one to remove it and provide the Microlife WatchBP Home-Nocturnal device and another one to bring it back. This will take approximately two weeks.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Athens, Grécia, 11527
- Sotiria General Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:ma
- Patients referred for high blood pressure
- Age over 30 years
- Untreated for hypertension or under stable treatment for 4 weeks or more
- Patients physically and mentally capable for self-measurement of blood pressure at home
- Written informed consent to participate in the study
Exclusion Criteria:
- Sustained arrythmia
- Pregnancy
- Symptomatic cardiovascular disease
- Any other serious disease (renal failure, heart failure, malignancy)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: All patients
All eligible patients in the study consist a single group and the same intervention is assigned to all of them.
|
Home Blood pressure Monitoring Nocturnal-Home Blood Pressure Monitoring Ambulatory Blood Pressure Monitoring
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Awake Systolic Home Blood Pressure Measurement
Prazo: 2 weeks
|
Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
|
2 weeks
|
|
Awake Diastolic Home Blood Pressure Measurement
Prazo: 2 weeks
|
Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
|
2 weeks
|
|
Asleep Systolic Home Blood Pressure Measurement
Prazo: 2 weeks
|
Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
|
2 weeks
|
|
Asleep Diastolic Home Blood Pressure Measurement
Prazo: 2 weeks
|
Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
|
2 weeks
|
|
Awake Systolic Ambulatory Blood Pressure Measurement
Prazo: 2 weeks
|
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed.
Measurements taken during patient's awake and asleep hours are analyzed separately.
|
2 weeks
|
|
Awake Diastolic Ambulatory Blood Pressure Measurement
Prazo: 2 weeks
|
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed.
Measurements taken during patient's awake and asleep hours are analyzed separately.
|
2 weeks
|
|
Asleep Systolic Ambulatory Blood Pressure Measurement
Prazo: 2weeks
|
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed.
Measurements taken during patient's awake and asleep hours are analyzed separately.
|
2weeks
|
|
Asleep Diastolic Ambulatory Blood Pressure Measurement
Prazo: 2weeks
|
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed.
Measurements taken during patient's awake and asleep hours are analyzed separately.
|
2weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Dippers Defined by ABPM and HBPM-Nocturnal
Prazo: 2 weeks
|
As Dippers are defined the patients who displayed a nocturnal fall (Daytime-Nighttime BP/Daytime BP) in Systolic and/or Diastolic Blood Pressure by 10% or more, by each method.
The rest of patients, with a nocturnal fall by less than 10% or even a rise of BP, are consequently defined as Non-Dippers.
|
2 weeks
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NOCTURNAL
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Blood Pressure Monitoring
-
Philips Clinical & Medical Affairs GlobalRecrutamentoUnidade de Terapia Intensiva | Cateter da Artéria Pulmonar (PAC) | Cateter de Swan-GanzEstados Unidos, Alemanha
-
St. Antonius HospitalRecrutamento
-
The Hong Kong Polytechnic UniversityConcluídoDispositivo ineficazHong Kong
-
Singapore General HospitalKK Women's and Children's Hospital; SingHealth PolyclinicsConcluído
-
Philips Clinical & Medical Affairs GlobalRecrutamentoCirurgia Não Cardíaca | Unidade de Cuidados Intensivos (UCI)Estados Unidos, Alemanha
-
Centre Hospitalier Universitaire de NiceRecrutamentoDoença de AlzheimerFrança
-
Beijing GoBroad HospitalRecrutamentoEsclerose Sistêmica | Nefrite Lúpica Refratária | Síndrome de Sjogren primária combinada com hipertensão pulmonarChina
-
Haydarpasa Numune Training and Research HospitalConcluídoDistúrbio hemorrágicoPeru
-
Rush University Medical CenterNational Institute of Neurological Disorders and Stroke (NINDS)RecrutamentoHemorragia intracerebral primáriaEstados Unidos
-
Biotronik SE & Co. KGRescindidoFibrilação atrial | Insuficiência Cardíaca (IC)França, Alemanha, Holanda, Bélgica, Suécia, Reino Unido, Tcheca