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Rehabilitation Program in Heart Failure With Preserved Ejection Fraction

17 de noviembre de 2014 actualizado por: Dr. Robert Klempfner Heart Rehabilitation Institute, Sheba Medical Center

Multi-Disciplinary Rehabilitation Program in Recently Hospitalized Patients With Preserved Ejection Fraction Heart Failure

The purpose of this prospective study is to determine whether comprehensive cardiac rehabilitation is superior to usual disease management in the treatment of patients with heart failure with preserved systolic function (HFpEF) recently discharged after an acute heart failure event.

The investigators hypothesize that the addition of bi-weekly structured exercise training and interaction with medical personnel will lead to a greater reduction in all cause hospitalization and mortality while providing additional functional and clinical benefits such as exercise capacity, quality of life and well-being.

Furthermore the investigators seek to establish clinical, laboratory and echocardiographic predictors of hospital readmissions and cardiovascular events in the predefined HFpEF population.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

Our primary objective is to test the hypothesis that comprehensive multi-disciplinary cardiac rehabilitation program is superior to usual care in the treatment of patients with HFpEF discharged after an acute heart failure event, and will result in a 25% reduction in the composite outcome of all cause hospitalizations and all-cause mortality after 1-year of follow-up. This objective represents both safety and efficacy end-point in a patient population with a high rate of co-morbidities, which may be affected as well. Previous observation has shown that these patients have a high rate of non-cardiac death in comparison with HFrEF, thus enhancing the importance of all-cause hospitalization and mortality as a primary end-point.

Secondary end-points that will be recorded include separate components of the primary end-point, time to first hospitalization, functional capacity measured by NYHA class, 6-minute walk test (6MWT), blood pressure during rest and exercise, fasting glucose and Hb A1C levels, BNP values and quality of life EQ5-D questionnaire.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

1100

Fase

  • No aplica

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

  • Israel
      • Ramat Gan, Israel
      • Tel Hashomer , Ramat Gan, Israel
        • Aún no reclutando
        • Sheba Medical Center, Cardiac Rehabilitation Institute
        • Contacto:
          • Robert Klempfner, MD
          • Número de teléfono: +972525506852
          • Correo electrónico: klempfner@gmail.com
        • Contacto:
        • Sub-Investigador:
          • Robert Klempfner, MD

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

21 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients >=21 years of age willing and able to sign consent forms
  • Hospitalization for acute heart failure (AHF) in one of the internal medicine departments participating in the study

  • AHF as the primary diagnosis as defined by:

    • (I) The presence of pulmonary congestion or edema on chest radiography OR
    • (II) Evidence of fluid retention (pedal edema, pleural effusion, ascites) not otherwise explained by other conditions (i.e. malignancy, nephrotic syndrome, liver cirrhosis, severe hypo-albuminemia, etc) AND

    • (III) Echocardiography demonstrating the presence of preserved systolic function

      • In cases where diagnosis is unclear BNP testing (with a cutoff value of >300 ng/dl) will be used.
      • If there is clinical suspicion of pulmonary disease investigators are encouraged to perform pulmonary function tests after the patient condition is stabilized.
  • Preserved systolic function as determined by in-hospital or recent (within 3 months) echocardiographic examination according to ESC guidelines and in the absence of hemodynamic significant valvular disease.
  • Stable clinical condition prior to discharge permitting the initiation of an exercise training program

Exclusion Criteria:

  • Hemodynamically significant valvular disease (severity > mild other than TR)
  • Acute coronary syndrome as the primary diagnosis
  • End stage heart failure - NYHA IV
  • Severe renal dysfunction - eGFR<30 ml/min/1.73m2 or renal replacement therapy
  • Inability to participate in an exercise program and comply with study protocol
  • Severe chronic obstructive pulmonary disease (COPD) (FEV1<50%) or asthma defined as severe
  • First episode of a hypertensive crisis event (without history of chronic heart failure)
  • Cognitive decline or major psychiatric pathology
  • Non ambulatory condition
  • Life expectancy < 12 months
  • Substance dependency
  • Inability to participate due to technical barriers such as a significant distance from a cardiac rehabilitation center

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cardiac Rehabilitation
Patients randomized to the multidisciplinary cardiac management program at the cardiac rehabilitation center will undergo evaluation by a trained rehabilitation physician and physiologist. The evaluation will include medical history, physical examination, vitals, review of post discharge graded exercise stress test and nursing staff consultation. Exercise prescription will be based on a pre-specified protocol in accordance with ESC position paper on cardiac rehabilitation of patients with heart failure.
Conductual: Cardiac Rehabilitation
Patients will participate in a 6-month cardiac rehabilitation program, consisting of structured, 60-minutes, bi-weekly exercise training sessions according to a predefined protocol. Institutional activity will be complemented by 120 minutes weekly home exercise prescribed by specialist in cardiac rehabilitation. Exercise prescription will be based on a symptom limited exercise test when clinically feasible and according with the patients' functional capacity, medical history and physiological values obtained prior to exercise. Target heart rate will be set initial as 50-60% of heart rate reserve and gradually increased up to 80% of HRR. Aerobic exercise will be complemented by resistance training of low intensity.
Otros nombres:
  • Entrenamiento de ejercicio
  • Multi-disciplinary cardiac rehabilitation program
Comparador activo: Internal Medicine
Following discharge, patients will return to the internal medicine (IM) outpatient clinics at 2-4 weeks, 3, and 6 months for consultation. These scheduled consultations will comprise of history taking, recording of any new events, physical examination and recommendations as clinically indicated.
Otro: Internal Medicine
Following discharge, patients will return to the IM outpatient clinics at 2-4 weeks, 3, and 6 months for consultation. These scheduled consultations will comprise of history taking, recording of any new events, physical examination and recommendations as clinically indicated. Target values for blood pressure and glucose control will be in accordance with current guidelines and special emphasis given to management of fluid retention.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Combined primary endpoint
Periodo de tiempo: 12 months following randomization
Combined all-cause mortality and hospitalizations at a 12-months follow-up
12 months following randomization

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Secondary endpoint - change in functional capacity and clinical status
Periodo de tiempo: 3 and 6 month follow-up after randomization
Secondary clinical outcomes will be collected during the 3 and 6 month follow-up visits and will include: blood pressure averages , HbA1C levels, assessment of NYHA class and global clinical assessment , 6-minute walk test and quality of life data as evaluated by the EQ-5D questionnaire
3 and 6 month follow-up after randomization
All cause mortality end-point
Periodo de tiempo: 12 months after randomization
12 months after randomization
Heart failure hospitalizations
Periodo de tiempo: 12 months after randomization
Number of HF hospitalizations as assessed by HF specialists blinded to patients allocation. Assessment will include medical record and hospital discharge letter review.
12 months after randomization

Colaboradores e Investigadores

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

Patrocinador

Sheba Medical Center

Colaboradores

The Gertner Institute

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 octubre de 2013

Finalización primaria (Anticipado)

1 de enero de 2016

Finalización del estudio (Anticipado)

1 de junio de 2016

Fechas de registro del estudio

Enviado por primera vez

30 de julio de 2013

Primero enviado que cumplió con los criterios de control de calidad

1 de agosto de 2013

Publicado por primera vez (Estimar)

2 de agosto de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

18 de noviembre de 2014

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

17 de noviembre de 2014

Última verificación

1 de noviembre de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • SHEBA-13-0246-RK-CTIL

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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