- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00005204
Blood Pressure and Diurnal Variation in Sodium, Potassium, and Water Excretion
Descripción general del estudio
Estado
Descripción detallada
BACKGROUND:
For decades excess sodium intake has been implicated in the etiopathogenesis of high blood pressure. Data from epidemiological, clinical, and animal experimental studies all suggest a direct casual association between excess salt intake and hypertension. Several investigators suggest that hypertension is the result of an inability of the kidney to excrete salt and water normally. It is hypothesized that the development of chronic blood pressure elevation results from the kidney's need to increase urine volume and sodium excretion -- in the presence of habitual high sodium intake -- in order to maintain homeostasis of the extracellular fluid volume.
Diurnal variations in excretion of sodium, chloride, potassium and water have been observed in several studies. Water and electrolyte excretion in normal individuals generally reaches a maximum sometime around midday with a minimum toward the end of the sleep period. These studies suggest that the daytime excretion rate exceeds the nighttime rate by 50 to 100 percent. Overnight urine collections have been used in many studies since they are easier to obtain, but they do not provide a direct estimate of the actual intake of sodium or potassium. In order to estimate actual intake, overnight values must be corrected to 24-hour values, that is, by multiplying the overnight values by previously determined ratios of 24-hour to overnight excretions. Preliminary studies by this group of investigators in hypertensives were the first which computed 24-hour to overnight ratios for excretion of sodium, potassium and creatinine in a definite way. This study in hypertensives showed a reversal of the diurnal cycle of sodium excretion. What is not clear in this study and others is whether the reversal is associated with hypertension or reflects decreased renal function with age or whether deterioration of renal function is due to the kidney readjusting its output of salt and water to maintain homeostasis in the face of both an excess sodium intake and a highly variable day to day intake. In addition, it may be that an abnormal diurnal pattern of sodium excretion may indicate that one is at risk of development of hypertension.
DESIGN NARRATIVE:
Each participant provided three 24-hour urine collections, divided into daytime and overnight specimens for the assessment of sodium, potassium, creatinine, and water excretion. Four blood pressure measurements were made. Height and weight were measured. Information was collected on demographic variables, alcohol intake, history and treatment of blood pressure, medication use, family history of high blood pressure, cigarette use, and changes in dietary habits. Analysis of variance was the primary method of data analysis.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Tipo de estudio
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Plan de estudios
¿Cómo está diseñado el estudio?
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1083
- R01HL038897 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Enfermedades cardíacas
-
Region SkaneInscripción por invitaciónInsuficiencia cardíaca New York Heart Association (NYHA) Clase II | Insuficiencia cardíaca New York Heart Association (NYHA) Clase IIISuecia
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University... y otros colaboradoresAún no reclutandoInsuficiencia Cardíaca Sistólica | Insuficiencia cardíaca con fracción de eyección reducida | Insuficiencia cardíaca Clase IV de la New York Heart Association | Insuficiencia cardíaca Clase III de la New York Heart AssociationPolonia
-
Novartis PharmaceuticalsTerminadoPacientes que completaron con éxito el período de tratamiento de 12 meses del estudio principal (receptores de Novo Heart) que estaban interesados en recibir tratamiento con EC-MPS
-
University of WashingtonAmerican Heart AssociationTerminadoInsuficiencia cardíaca, congestiva | Alteración mitocondrial | Insuficiencia cardíaca Clase IV de la New York Heart AssociationEstados Unidos