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Pruebas de esfuerzo en cinta rodante para la evaluación de la eficacia en ensayos aleatorizados y controlados

Andrew Morrow1, Robin Young2, George R Abraham3

  • 1British Heart Foundation Glasgow Cardiovascular Research Centre, School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, United Kingdom (UK).

American heart journal
|February 13, 2026
PubMed
Resumen
Este resumen es generado por máquina.

Las pruebas de esfuerzo en cinta rodante no mostraron que el zibotentán mejorara la duración del ejercicio para la angina microvascular. Las mejoras en las pruebas de esfuerzo ocurrieron con el tiempo, independientemente del tratamiento, y se relacionaron con el sexo femenino.

Palabras clave:
angina con ausencia de obstrucción en arterias coronariasantagonista del receptor de endotelinaprueba de esfuerzoangina microvascularfarmacoterapiapunto final del ensayo

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Área de la Ciencia:

  • Cardiología
  • Ensayos Clínicos
  • Farmacología

Sus antecedentes:

  • Las pruebas de esfuerzo en cinta rodante son una medida estándar de la capacidad funcional y la isquemia miocárdica, a menudo utilizadas como punto final en ensayos clínicos.
  • La angina microvascular es una afección que afecta la capacidad funcional y se están investigando terapias modificadoras de la enfermedad.
  • Se evaluó el zibotentán, un antagonista selectivo del receptor de endotelina A, por su potencial para tratar la angina microvascular.

Objetivo del estudio:

  • Evaluar la eficacia del zibotentán en la mejora de la capacidad funcional y los síntomas de angina en pacientes con angina microvascular.
  • Analizar los cambios en la duración del ejercicio a lo largo de las visitas secuenciales al estudio dentro del ensayo.
  • Identificar los factores asociados con los cambios en la duración del ejercicio dentro del ensayo.

Principales métodos:

  • Se empleó un diseño de ensayo cruzado, aleatorizado y doble ciego.
  • Los participantes recibieron zibotentán (10 mg al día durante 12 semanas) o un placebo.
  • La medida principal de resultado fue la duración del ejercicio evaluada mediante pruebas de esfuerzo en cinta rodante.

Principales resultados:

  • El zibotentán no mejoró significativamente la duración del ejercicio ni los síntomas de angina en comparación con el placebo.
  • La duración de la prueba de esfuerzo aumentó progresivamente en las visitas secuenciales al estudio para todos los participantes, independientemente del tratamiento.
  • Esta mejora en la duración del ejercicio se asoció significativamente con el sexo femenino (p=0,002).

Conclusiones:

  • Las pruebas de esfuerzo en cinta rodante pueden tener limitaciones como punto final objetivo de eficacia en ensayos aleatorizados.
  • La mejora observada en la duración del ejercicio con el tiempo sugiere un efecto de aprendizaje o adaptación, no atribuible únicamente al fármaco.
  • Se identificó el sexo femenino como un factor asociado con la mejora de la duración del ejercicio dentro del ensayo.