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Human B-type Natriuretic Peptide (BNP) (Nesiritide) to Help Heart, Kidney, and Hormonal Functions in Persons With Lower Heart Pumping Function

4 de febrero de 2014 actualizado por: Horng Chen, Mayo Clinic

To Define in Human Preclinical Systolic Dysfunction (PSD) the Actions of Chronic Administration of Subcutaneous (SQ) BNP on the Left Ventricular, Renal, and Humoral Function and on the Integrated Response to Acute Sodium Loading

The following are done for screening procedures to determine if patients are eligible for this study: blood count, kidney and liver blood tests. Patients will complete a 6-minute walk test. Patients will be instructed to follow a no-added-salt diet for 1-3 weeks before the study and for the whole duration of the study. Diet instructions will be given to the patient and the patient will collect his/her urine for 24 hours before the active study day. Patients will need to avoid strenuous exercise and abstain from smoking, alcohol, and caffeine for 3 days prior to the study days. Patients will remain on their regular medications.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Participants in this study will be randomized to receive BNP or placebo (an inactive, saline shot). The participant will need to give themselves a shot in their stomach (similar to diabetics giving themselves insulin) twice a day for twelve weeks. The study requires a screening visit to determine eligibility and discuss the study. At this visit a blood draw for heart and liver function and a six minute walk will be done. There will also be two other outpatient visits and two inpatient stays, for 48 hours, in the General Clinical Research Center (GCRC) at St. Marys Hospital. During the two in-patient stays in the GCRC, blood and urine samples will be done to get heart and kidney function as well as a research echo. After enrollment, the study lasts for twelve weeks. There is a one week visit in outpatient setting getting a blood draw and a 6 week visit in outpatient setting to get a blood draw, 24 hour urine collection and resupply the study medication. There is a one week visit in outpatient setting getting a blood draw and a 6 week visit in outpatient setting to get a blood draw, 24 hour urine collection and resupply the study medication.

Tipo de estudio

Intervencionista

Inscripción (Actual)

37

Fase

  • Fase 2
  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Mayo Clinic

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Subjects with an ejection fraction of less than 45%
  • No clinical signs or symptoms of congestive heart failure
  • Ability to walk a minimal distance of > 450 meters on a 6-minute walk. If the subject is not able to walk 450 meters due to pain in hips and knees and not fatigue or shortness of breath, they will still qualify for the protocol.
  • The subjects will all be on stable doses of an angiotensin converting enzyme (ACE) inhibitor for two weeks prior to the active study date.
  • Therapy with other vasodilators, beta-receptor antagonists, digoxin and antiarrhythmic medications will be allowed, however, all medications must be at stable doses two weeks prior to the study date.

Exclusion criteria:

  • Myocardial infarction within 3 months of screening
  • Unstable angina within 14 days of screening, or any evidence of myocardial ischemia
  • Significant valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis
  • Severe congenital heart diseases
  • Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening
  • Second or third degree heart block without a permanent cardiac pacemaker
  • Stroke within 3 months of screening, or other evidence of significantly compromised central nervous system (CNS) perfusion
  • Total bilirubin of > 1.5 mg/dL or other liver enzymes >1.5 times the upper limit of normal
  • Serum creatinine of > 3.0 mg/dL
  • Serum sodium of < 125 milliequivalent (mEq)/dL or > 160 mEq/dL
  • Serum potassium of < 3.5 mEq/dL or > 5.0 mEq/dL change to 5.3
  • Serum digoxin level of > 2.0 ng/ml
  • Systolic pressure of < 85 mmHg
  • Hemoglobin < 10 gm/dl

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Nesiritide
Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
Droga: Nesiritide
Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
Otros nombres:
  • Natrecor
  • Human B-type natriuretic peptide (BNP)
Comparador de placebos: Placebo
Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
Droga: Placebo
Normal saline will be used for placebo.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Change in Urinary Sodium Excretion in Response to Saline Load
Periodo de tiempo: baseline, 12 weeks
baseline, 12 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Urine Flow in Response to Saline Load
Periodo de tiempo: baseline, 12 weeks
baseline, 12 weeks
Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) in Response to Saline Load
Periodo de tiempo: baseline, 12 weeks
Kidney function was measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m^2 of body surface area is considered to be impaired kidney function.
baseline, 12 weeks
Change in Left Ventricular Mass Index
Periodo de tiempo: baseline, 12 weeks
Left ventricular mass index (LVMI) is a surrogate of left ventricular hypertrophy and a predictor of cardiac morbidity and mortality in adults with hypertension. LVMI was measured with echocardiography, indexed to body surface area estimated by left ventricular (LV) cavity dimension and wall thickness at end-diastole.
baseline, 12 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Mayo Clinic

Colaboradores

National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2006

Finalización primaria (Actual)

1 de abril de 2011

Finalización del estudio (Actual)

1 de mayo de 2013

Fechas de registro del estudio

Enviado por primera vez

29 de noviembre de 2006

Primero enviado que cumplió con los criterios de control de calidad

29 de noviembre de 2006

Publicado por primera vez (Estimar)

30 de noviembre de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

17 de marzo de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

4 de febrero de 2014

Última verificación

1 de febrero de 2014

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 05-004186
  • P01HL076611 (Subvención/contrato del NIH de EE. UU.)
  • UL1RR024150 (Subvención/contrato del NIH de EE. UU.)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

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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