- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02243514
Intravascular Ultrasound Evaluation of Renal Nerves in Different Diseases
Intravascular Ultrasound Evaluation of the Renal Nerves Remodeling in Different Diseases
Descripción general del estudio
Estado
Condiciones
Descripción detallada
People eligible for this study will be divided into 4 groups according to the eligibility criteria(Resistant Hypertension Group,Essential Hypertension Group, Chronic Heart Failure Group and Control Group), about 15 objects for each, totally 60 objects are going to be recruited.
Before the intravascular ultrasound examination, ambulatory blood pressure, ECG, plasma catecholamine hormones, renin-angiotension-aldosterone, ect. will be measured. An intravascular ultrasound examination will be taken after all of these have been done.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jing Huang, MD
- Número de teléfono: 0086-13508312022
- Correo electrónico: huangjing@cqmu.edu.cn
Ubicaciones de estudio
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Chongqing
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Chongqing, Chongqing, Porcelana, 400010
- Reclutamiento
- The 2nd affiliated Hospital of Chongqing Medical University
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Contacto:
- Jing Huang, MD
- Número de teléfono: 0086-13508312022
- Correo electrónico: huangjing@cqmu.edu.cn
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Investigador principal:
- Jing Huang, MD
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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:
Resistant hypertension group
- blood pressure remains above goal in spite of the concurrent use of three or more anti-hypertensive agents(including a diuretic) at adequate doses.
- agrees to have the study procedure(s) performed and additional procedures and evaluations
Essential hypertension group
- systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, or current use of anti-hypertensive medication with a normal blood pressure or mean ambulatory blood pressure during the 24-hour≥130/80 mmHg.
- not resistant to pharmacotherapy.
- agrees to have the study procedure(s) performed and additional procedures and evaluations
Chronic heart failure group
- New York Heart Association class II-III symptoms, or American College of Cardiology(ACC) / American Heart Association(AHA) heart failure classification B-C class of chronic heart failure.
- currently or prior have the signs of heart failure, such as elevated jugular venous pressure, peripheral edema, pulmonary crepitations, ect.
- Systolic left ventricular dysfunction as assessed by echocardiogram with left ventricular ejection fraction < 40%.
- agrees to have the study procedure(s) performed and additional procedures and evaluations
Control group
- no history of arterial hypertension, heart failure and diabetes
- going to take a vascular interventional examination during hospitalization
- agrees to have the study procedure(s) performed and additional procedures and evaluations
All patients have full capacity for civil conduct and agree to sign the Medical Informed Consent.
Exclusion Criteria:
- hemodynamically or anatomically significant renal artery stenosis.
- renal artery variation.
- renal artery diameter < 4 mm, trunk length < 20 mm.
- secondary hypertension with known causes and pseudo-hypertension.
- has experienced myocardial infarction, unstable angina pectoris, or cerebrovascular accident within 6 months.
- has an implantable cardioverter defibrillator (ICD) or pacemaker.
- requires respiratory support.
- is pregnant or planning to be pregnant.
- cardiovascular diseases with sever hemodynamic disorder.
- type 1 diabetes mellitus.
- currently enrolled in another investigational drug or device trial.
- civil disability or limited capacity for civil conduct.
- other conditions researchers considered unsuitable for enrolled in the trial.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Control
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Hipertensión esencial
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Insuficiencia cardíaca crónica
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Resistant hypertension
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number increase of Renal nerves in patients with sympathetic over-activity diseases
Periodo de tiempo: A duration of the whole research stage, an expected average of 1/2 year
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Total number of the renal nerve of each patient(automatic identification by the embedded software in the ultrasound imaging host/counting manually): Number of Nerve Bundles;
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A duration of the whole research stage, an expected average of 1/2 year
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Area increase of Renal nerves in patients with sympathetic over-activity diseases
Periodo de tiempo: A duration of the whole research stage, an expected average of 1/2 year
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Total area of the renal nerve (measured by ultrasound imaging host) of each patient: square millimeter (mm²)=∑= Nerve 1(length*width)+ Nerve 2(length*width)+ ......+ Nerve n(length*width);
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A duration of the whole research stage, an expected average of 1/2 year
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The increase of the ratio of nerve area/artery wall area in patients with sympathetic over-activity diseases.
Periodo de tiempo: A duration of the whole research stage, an expected average of 1/2 year
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A duration of the whole research stage, an expected average of 1/2 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants with Serious and Non-Serious Adverse Events Related to The Intervention Procedure
Periodo de tiempo: Participants will be followed for the duration of the operation time, an expected average of 0.5-1 hours
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Renal arteriography will be carried out post operation to evaluate the possibility of renal artery injuries caused by this procedure, which including:
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Participants will be followed for the duration of the operation time, an expected average of 0.5-1 hours
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Jing Huang, MD, Dept. of Cardiology, the 2nd affiliated hospital of Chongqing Medical University
Publicaciones y enlaces útiles
Publicaciones Generales
- Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.
- D'Elia E, Pascale A, Marchesi N, Ferrero P, Senni M, Govoni S, Gronda E, Vanoli E. Novel approaches to the post-myocardial infarction/heart failure neural remodeling. Heart Fail Rev. 2014 Sep;19(5):611-9. doi: 10.1007/s10741-013-9415-6.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- US-RNRE
- NSFC81370440 (Otro número de subvención/financiamiento: National Natural Science Foundation of China)
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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