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- Ensayo clínico NCT03826745
The CHYMASE Angiotensin-(1-12) Axis in Cardiovascular Disease
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Study is to determine the presence of the human sequence on Ang-(1-12) in the plasma of normal male and female normotensive, hypertensive and/or resistant hypertensive subjects.
To measure concentrations of Ang-(1-12) in either serum or spot urine collections from male and female normal, hypertensive and/or resistant hypertensive subjects.
To assess whether chymase activity can be detected in human serum and urine using the radiolabeled amino acid sequence of 1251-Ang-(1-12)
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Henry A Punzi, MD
- Número de teléfono: 972-478-7700
- Correo electrónico: punzimedcenter@aol.com
Copia de seguridad de contactos de estudio
- Nombre: Kathy Cassidy, RN
- Número de teléfono: 972-478-7700
- Correo electrónico: clinicalresearch@punzimedicalcenter.com
Ubicaciones de estudio
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Texas
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Carrollton, Texas, Estados Unidos, 75006
- Reclutamiento
- Punzi Medical Center
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Contacto:
- Henry A Punzi, MD
- Número de teléfono: 972-478-7700
- Correo electrónico: punzimedcenter@aol.com
-
Contacto:
- Kathy Cassidy, RN
- Número de teléfono: 972-478-7700
- Correo electrónico: clinicalresearch@punzimedicalcenter.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Cable of reading, comprehending the consent process and providing written informed consent to participate in the study.
- Male or female equal/over 40 years of age.
- Currently being treated with 3 medications and are not at goal seated, Blood pressure of Systolic blood pressure less 140 mmHg and/or Diastolic blood pressure less 90 mmHg (Diabetic patients goal seated blood pressure- Systolic blood pressure less 130 and/or Diastolic blood pressure less 80) OR
- Stage I-II hypertension defined as a baseline mean seated cuff Diastolic blood pressure of equal/over 90 mmHg and equal/less 115 mmHg and/or Systolic blood pressure equal/over 140 mmHg and equal/less 180 mmHg OR
- Normotensive patients defined as a blood pressure less 140/90 mmHg
- Women may be enrolled if all three of the following criteria are met:
- Have a negative urine pregnancy test at screening, for females of childbearing potential
- Are not breastfeeding
- Do not plan t become pregnant during the study
- And if one of the following three criteria is met:
- Have had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form
- Have been postmenopausal for at least 1 year
- Are of childbearing potential and will practice one of the following methods of birth control throughout the study: oral, patch, injectable, or implantable hormone contraception, intrauterine device, diaphragm plus spermicide or female condom plus spermicide. Abstinence, partner's vasectomy are not acceptable methods of contraception.
Exclusion Criteria:
- Patients with severe hypertension (mean seated cuff Diastolic blood pressure over 115 mmHg or mean seated Systolic blood pressure over 180 mmHg) or any form of secondary hypertension at time of screening.
- Patients within the past 6 months with a history of hypertensive encephalopathy, stroke or transient ischemic attack.
- Patients within the last 6 months with a history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary bypass graft, valvular surgery or unstable angina.
- Patients with a history of heart block greater than First Degree Sino atrial Block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial Fibrillation, Atrial Flutter, Congestive Heart Failure, or other manifestations of clinically significant cardiac valvular disease.
- Patients with hemodynamically significant cardiac valvular disease.
- Patients with evidence of significant chronic renal impairment as indicated by a serum creatinine of over 2.5mmg/dl at Visit 1.
- Patients with evidence of liver disease as indicated by Aspartate transaminase (Serum glutamic oxaloacetic) or Alanine aminotransferase (Serum glutamic pyruvic transaminase) over 2.5 times or total bilirubin over 1.5 times, the upper limit of the laboratory normal range at Visit 1.
- Patients who demonstrate other laboratory test values deviating from the normal range which are considered to be clinically significant by the investigator.
- Patients with insulin and non-insulin dependent diabetes mellitus not controlled on diet, insulin or oral hypoglycemic as defined by a Hemoglobin A1c over 10.5 % at Visit 1.
- Severe psychological or emotional condition which may interfere with participation in the study.
- History of or current use of illicit drugs or alcohol abuse.
- Participation in a clinical trial and taking any investigational drug within 30 days prior to enrolling into the study (Visit 1).
- A physical condition that would limit accurate Blood pressure measurement.
- Any other medical condition which, in the Investigator's opinion, may render the patient unable to complete the study or which would interfere with optimal participation in the study or produce significant risk to the patient.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Presence of Ang-(1-12) in Human Plasma/Urine
Periodo de tiempo: one day
|
Determine the presence of the human sequence of Ang-(1-12) in the plasma of normal male and female normotensive, hypertensive and/or resistant hypertensive subjects.
|
one day
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- PMC-60-009
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA 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. .
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