- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01251406
Efficacy and Safety of Human Neuregulin-1 to Treat Stable Chronic Heart Failure (ZS-01-210)
A Randomized, Parallel, Placebo-controlled, Double-blind Phase IIa Study of Efficacy and Safety of Recombinant Human Neuregulin-1 (Neucardin) in Subjects With Stable Chronic Heart Failure
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This randomized, parallel, placebo-controlled, double-blind, multi-center study will assess the safety and efficacy of rhNRG-1 also known as Neucardin as a treatment for stable chronic heart failure.
A total of 120 subjects, who have chronic heart failure with a NYHA classification of II or III, and are on a stable regimen of ACEI/angiotensin receptor blocker (ARB), beta-blocker, and/or diuretic for at least 3 months prior to receiving study medication and anticipated to remain on the stable regimen through the treatment period can enroll as per specific inclusion and exclusion criteria.
Subjects will be hospitalized for 10 days during the treatment period and will be infused subcutaneously with rhNRG-1 or placebo.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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La Jolla, California, Estados Unidos, 92037
- University of California, San Diego
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Los Angeles, California, Estados Unidos, 90033
- Metabolic Clinic and Research Center
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Los Angeles, California, Estados Unidos, 90033
- USC Cardiovascular Division
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Tustin, California, Estados Unidos, 92780
- Orange County Research Center
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Colorado
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Denver, Colorado, Estados Unidos, 80045
- University of Colorado Denver
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Florida
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Clearwater, Florida, Estados Unidos, 33756
- Clearwater Cardiovascular & Interventional Consultants, MD, PA
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Tampa, Florida, Estados Unidos, 33606
- University of South Florida
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa Hospitals and Clinics
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Louisiana
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Kenner, Louisiana, Estados Unidos, 70065
- MedPharmics, LLC.
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Metairie, Louisiana, Estados Unidos, 70006
- Benchmark Research
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Texas
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Houston, Texas, Estados Unidos, 77002
- East Texas Cardiology
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Plano, Texas, Estados Unidos, 75075
- The Medical Center of Plano
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Virginia
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Norfolk, Virginia, Estados Unidos, 23507
- Sentara Cardiovascular Research Institute
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age > 18 years.
- Male or female subjects.
- Have chronic heart failure defined as NYHA classification of II or III.
- Be on a stable regimen of ACEI/ARB and/or beta-blocker 3 months prior to receiving study medication and are expected to remain on a stable HF medication regime throughout the duration of the trial.
- Left ventricular ejection fraction (LVEF) of < 35% as determined at screening by 2-D echocardiography.
- Is able to understand and provide informed consent.
- If subject has dilated cardiomyopathy, ischemic heart disease or corrected valvular heart disease, and had surgery to repair or replace value, the surgery must have been performed 3 months prior to receiving study medication and the surgical area is functioning normally.
- Proper birth control must be used at least 3 weeks prior to the study (women only), during the infusion period of study drug (men and women), 4-weeks after study drug administration (men and women) and the remaining 11 months in the study follow-up (women). Women must have a negative pregnancy test at screening.
- No greater than mild pericardial effusion < 0.5 cm on echocardiography (roughly corresponds to < 100 mL).
- Have an implantable cardioverter-defibrillator (ICD). The ICD should have been implanted at least 3 months prior to receiving study medication. Patients should undergo interrogation of their ICDs between 1 and 7 days before randomization to drug for the previous thirty (30) days. This interrogation would include surveillance for ventricular arrhythmias as well as assessment of ICD discharge(s) and/or anti-tachycardia pacing.
Exclusion Criteria:
- Has chronic heart failure classified as NYHA Class I or IV.
- Has a history of any malignancy or positive test as specified in the pre-cancer screening.
- Have other conditions which in the opinion of the investigator preclude participation in the study, e.g. serious co-morbidity, known or suspected substance abuse or non-compliance.
- Has a body weight >350lbs.
- Has had any cause hospitalization 30 days prior to screening.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Placebo
Subcutaneous administration for daily for 8 hours a day for 10 days
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Daily subcutaneous administration for 8 hours a day for 10 days
Otros nombres:
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Experimental: rhNRG-1 Dose 1
Subcutaneous administration for daily for 8 hours a day for 10 days
|
Daily subcutaneous administration for 8 hours a day for 10 days
Otros nombres:
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Experimental: rhNRG-1 Dose 2
Subcutaneous administration for 8 hours a day for 10 days
|
Daily subcutaneous administration for 8 hours a day for 10 days
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline in LVEF
Periodo de tiempo: 30 days
|
Compared to baseline and placebo
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30 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Six (6) minute walk test
Periodo de tiempo: Day 30, 90, 180, 365
|
Compared to baseline and placebo
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Day 30, 90, 180, 365
|
Quality of Life Questionnaire (Kansas City Cardiomyopathy Questionnaire)
Periodo de tiempo: Day 30, 90, 180 and 365
|
Compared to baseline and placebo
|
Day 30, 90, 180 and 365
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NYHA class status
Periodo de tiempo: Day 30, 90, 180 and 365
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Compared to baseline and placebo
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Day 30, 90, 180 and 365
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All cause mortality and all cause hospitalization
Periodo de tiempo: Days 30, 90, 180 and 365
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Compared to baseline and placebo
|
Days 30, 90, 180 and 365
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Change in LVESV and LVEDV
Periodo de tiempo: Day 30
|
Compared to baseline and placebo
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Day 30
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Barry Greenberg, MD, University of California, San Diego
- Investigador principal: Uri Elkayam, MD, LAC+USC Medical Center
Publicaciones y enlaces útiles
Publicaciones Generales
- Xu Y, Li X, Liu X, Zhou M. Neuregulin-1/ErbB signaling and chronic heart failure. Adv Pharmacol. 2010;59:31-51. doi: 10.1016/S1054-3589(10)59002-1.
- Jabbour A, Hayward CS, Keogh AM, Kotlyar E, McCrohon JA, England JF, Amor R, Liu X, Li XY, Zhou MD, Graham RM, Macdonald PS. Parenteral administration of recombinant human neuregulin-1 to patients with stable chronic heart failure produces favourable acute and chronic haemodynamic responses. Eur J Heart Fail. 2011 Jan;13(1):83-92. doi: 10.1093/eurjhf/hfq152. Epub 2010 Sep 1.
- Gao R, Zhang J, Cheng L, Wu X, Dong W, Yang X, Li T, Liu X, Xu Y, Li X, Zhou M. A Phase II, randomized, double-blind, multicenter, based on standard therapy, placebo-controlled study of the efficacy and safety of recombinant human neuregulin-1 in patients with chronic heart failure. J Am Coll Cardiol. 2010 May 4;55(18):1907-14. doi: 10.1016/j.jacc.2009.12.044.
- Liu X, Gu X, Li Z, Li X, Li H, Chang J, Chen P, Jin J, Xi B, Chen D, Lai D, Graham RM, Zhou M. Neuregulin-1/erbB-activation improves cardiac function and survival in models of ischemic, dilated, and viral cardiomyopathy. J Am Coll Cardiol. 2006 Oct 3;48(7):1438-47. doi: 10.1016/j.jacc.2006.05.057. Epub 2006 Sep 14.
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ZS-01-210
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