- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02524873
Relationship Between Genes Important in Blood Pressure Regulation and Blood Pressure Therapy in Hypertension
Assessment of the Relationship Between Genes That Encode Proteins Important in Blood Pressure Regulation and Blood Pressure Therapy in Patients With Hypertension
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
2.1 Study Design and Protocol Overview This is a post-hoc association study of patients who have been diagnosed with high blood pressure and have been stable on medication treatment for at least 6 months. The purpose of this study is to evaluate the relationship between optimal medication therapy (or the therapy that has resulted in the most stable blood pressure for that particular patient) and the predicted optimal medication therapy based on a patient's genetic profile.
Chart reviews for the patient's history of antihypertensive therapy will be coupled with buccal swabs and blood pressure readings collected from eligible patients who have provided informed consent. The swab will be analyzed for fourteen genetic variants that are associated with antihypertensive therapy response (efficacy, side-effects).
2.2 Study Objective To assess the relationship between the drug therapy class/combination of therapy classes that resulted in the best blood pressure control for a patient vs. what the Geneticure high blood pressure panel would have predicted.
2.3 Secondary Objectives
- To assess the clinical time to achieve optimal blood pressure treatment.
- To assess the number of office visits required to achieve optimal blood pressure treatment.
Tipo de estudio
Inscripción (Actual)
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:
- Subject is able and willing to provide informed consent
- Subject is ≥ 30 and ≤ 70 years of age
- Subject with diagnosis of Hypertension for a minimum of 1 year
- Subject has been on the same class/classes of blood pressure medication for a minimum of 6 months. Note: A change in dosage, frequency, or specific medication is acceptable as long as there have been no changes to the class/classes of medications prescribed.
- Subject with a Body Mass Index (BMI) ≥ 19 and ≤ 35
Subject is currently prescribed and taking one of the following classes of medications alone or in combination with each other or a Ca+ channel blocker.
- Diuretics
- ACE Inhibitors
- Angiotensin Receptor Blocker (ARB)
- Beta-blockers
Exclusion Criteria:
- Subject has clinically significant kidney disease as determined by the investigator.
- Subject has clinically significant cardiac disease as determined by the investigator.
- Subject has clinically significant vascular disease as determined by the investigator.
- Subject has a diagnosis of secondary hypertension or is experiencing a complication of pregnancy.
- Subject is currently prescribed and taking any additional class of medication(s) for high blood pressure not included in the list above, with the exception of a Ca+ channel blocker.
- Subject has Systolic BP > 190 or Diastolic BP > 120 documented within the six months prior to visit.
- Subject has a regular alcohol intake of greater than 21 units per week in the past 6 months
- Subject has smoked greater than two packs of cigarettes (total) or equivalent nicotine intake in the past 6 months.
- Subject has an anticipated survival less than 12 months.
- Any other reason that the subject is inappropriate for study enrollment in the opinion of the Investigator.
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 |
---|---|---|
Ambulatory blood pressure changes (using sphygmomanometry) in response to therapy according to genes important in blood pressure regulation
Periodo de tiempo: one year
|
To assess the relationship between the drug therapy class/combination of therapy classes that resulted in the best blood pressure control for a patient vs. what the Geneticure high blood pressure panel would have predicted.
We will assess blood pressure values (systolic and diastolic blood pressure, in mmHg) at rest in patients on different blood pressure medications.
|
one year
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
The clinical time to achieve optimal blood pressure treatment
Periodo de tiempo: One year
|
One year
|
The number of office visits required to achieve optimal blood pressure treatment.
Periodo de tiempo: One year
|
One year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Krista Kleve, RCRI
Publicaciones y enlaces útiles
Publicaciones Generales
- Johnson MW, Sprissler R, Olson TP, Beenken GW, Snyder EM. Multi-Gene Pharmacogenetics and Blood Pressure Control in Patients with Hypertension. The FASEB Journal 30:942.1. 2016
- Johnson MW, Sprissler R, Olson TP, Beenken GW, Snyder EM. Time to Blood Pressure Control According to Drug Class in Patients with Hypertension. The FASEB Journal 30:941.12. 2016.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
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 (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
- GTC01
Plan de datos de participantes individuales (IPD)
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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. .