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Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker (OPTPACE-HF)

28 de abril de 2026 actualizado por: Juwon Kim, Samsung Medical Center

Clinical and Hemodynamic Outcomes of OPTimized PACing StratEgies in Heart Failure Patients With Pacing Indications: Randomized-Controlled Trial (OPTPACE-HF)

This study aims to evaluate the clinical impact of an optimized pacing strategy in patients with heart failure.

  • Intervention: Adjustment of the pacemaker lower rate limit to an individualized, hemodynamically optimized heart rate.
  • Primary Endpoint: Heart failure symptoms, assessed by the Kansas City Cardiomyopathy Questionnaire score.
  • Hypothesis: In patients with heart failure requiring permanent pacing, an optimized pacing strategy will lead to a significant improvement in heart failure symptoms (Kansas City Cardiomyopathy Questionnaire score) at 12 months compared with the conventional pacing strategy.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Heart failure is a growing health concern with increasing prevalence in the aging population, and permanent pacemaker implantation is frequently required due to concomitant bradyarrhythmias. Heart rate is closely associated with hemodynamic status in patients with heart failure; however, evidence guiding the optimal pacemaker lower rate setting remains limited. Although the conventional lower rate is typically set at 50-60 bpm, recent studies suggest that a moderately increased pacing rate may improve hemodynamics and clinical outcomes. Furthermore, advances in physiological pacing techniques, such as conduction system pacing, provide the potential for greater clinical benefits through optimized heart rate settings in this patient population.

Enrolled subjects are randomized in a 1:1 ratio into either the optimized pacing group or the conventional pacing strategy group based on stratification factors.

The optimized pacing group undergoes post-procedural right heart catheterization with adjustments to the lower rate limit, where the heart rate (HR) that yields the lowest mean pulmonary capillary wedge pressure (mPCWP) or the highest cardiac output is determined as the optimal HR. In the conventional pacing strategy group, the lower rate limit is set at 60 bpm. Clinical symptoms and parameters of both groups are subsequently compared over a one-year follow-up period.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

106

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.

Estudio Contacto

  • Nombre: Juwon Kim, MD
  • Número de teléfono: 82-10-2079-8154
  • Correo electrónico: abcd186a@naver.com

Ubicaciones de estudio

  • Corea del Sur
    • Seoul
      • Seoul, Seoul, Corea del Sur, 06351
        • Reclutamiento
        • Samsung Medical Center
        • Contacto:
          • Juwon Kim, MD
          • Número de teléfono: 82-2-3410-3419
          • Correo electrónico: abcd186a@naver.com

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Patients with symptomatic bradycardia who meet the indication for permanent pacemaker implantation and fulfill one of the following conditions:

    1. Sick sinus syndrome with or without impaired atrioventricular conduction
    2. Persistent or permanent atrial fibrillation with slow ventricular response
    3. Chronotropic incompetence
  • Patients diagnosed with heart failure with left ventricular ejection fraction ≥ 50% on transthoracic echocardiography with at least one of the following:
  • H2FPEF score ≥ 6 or HFA-PEFF score ≥ 5
  • N-terminal pro-B-type natriuretic peptide ≥ 300 pg/mL (sinus rhythm) or ≥ 600 pg/mL (atrial fibrillation)
  • Prior hospitalization for heart failure or documented use of loop diuretics for heart failure symptoms

Exclusion Criteria:

  • Patients expected to have a ventricular pacing burden ≥ 20% without sufficient capture of cardiac physiologic pacing, which includes biventricular pacing, His bundle pacing, and left bundle branch area pacing.

(Sufficient cardiac physiologic pacing is defined as a paced QRS duration ≤ 140 ms.)

  • Patients not expected to achieve sufficient pacing dependency, defined as:

    1. In sinus rhythm: baseline atrial rate > 60 bpm on Holter monitoring or inpatient ECG monitoring
    2. In atrial fibrillation/flutter: baseline ventricular rate > 60 bpm on Holter monitoring or inpatient ECG monitoring
  • Patients with contraindications to permanent pacemaker implantation
  • Patients with moderate or greater valvular stenosis or regurgitation.
  • Patients with dyspnea not attributable to heart failure, due to uncontrolled comorbid conditions
  • Pregnant or breastfeeding women.
  • Patients who have refused active treatment.

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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Optimized pacing strategy

Optimized Pacing Strategy

  • Definition of Optimal Heart Rate: After permanent pacemaker implantation, a hemodynamic evaluation will be performed using right heart catheterization with stepwise incremental pacing rates of 60, 70, 80, and 90 bpm. If the optimal heart rate is identified at one of these 10-bpm intervals, additional assessments will be conducted in 5-bpm increments around that rate to further refine the optimal pacing rate.
  • Invasive hemodynamic parameters assessed include: Mean pulmonary capillary wedge pressure, Cardiac output (thermodilution)
  • The optimal heart rate is defined as the pacing rate associated with the lowest mean pulmonary capillary wedge pressure or highest cardiac output.
  • To ensure hemodynamic stabilization, a 5-minute washout period will be applied between rate changes.
  • To minimize the confounding effects of intrinsic bradycardia below 60 bpm, optimized pacing will be performed after a stabilization period of 2 weeks following permanent pacemaker.
Procedimiento: Adjustment of the pacemaker/ICDs lower rate limit (LRL)
Optimized Pacing Strategy
Comparador activo: Conventional pacing strategy

Conventional Pacing Strategy

• The conventional pacing group will have the pacemaker's lower rate limit set at a fixed 60 bpm, in accordance with current standard practice.
Procedimiento: Conventional lower rate (60bpm)
Conventional Pacing Strategy

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Kansas City Cardiomyopathy Questionnaire
Periodo de tiempo: From enrollment to 1year after the procedure
Higher scores indicate better health status and a higher quality of life, score 0 to 100
From enrollment to 1year after the procedure

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
NTproBNP
Periodo de tiempo: From enrollment to 1year after the procedure
pg/mL (picograms per milliliter)
From enrollment to 1year after the procedure
Functional status (NYHA class)
Periodo de tiempo: From enrollment to 1year after the procedure
class I to IV, higher NYHA classes indicate poorer functional status.
From enrollment to 1year after the procedure
Distance in 6-minute walk test
Periodo de tiempo: From enrollment to 1year after the procedure
m
From enrollment to 1year after the procedure
Occurrence of atrial fibrillation
Periodo de tiempo: From enrollment to 1year after the procedure
Documented incidence of atrial fibrillation on 12-lead ECG
From enrollment to 1year after the procedure
Atrial fibrillation burden
Periodo de tiempo: From enrollment to 1year after the procedure
Atrial fibrillation burden(%) recorded by CIEDs
From enrollment to 1year after the procedure
Invasive hemodynamics parameters in right heart catheterization
Periodo de tiempo: At the time of CIED implantation
pressure of RA, RV, PA, PCWP as mmHg Cardiac output as L/min (Liters per minute)
At the time of CIED implantation
CIED Battery longevity
Periodo de tiempo: From enrollment to 1year after the procedure
year
From enrollment to 1year after the procedure
All-cause mortality
Periodo de tiempo: From enrollment to 1year after the procedure
All-cause mortality rate(%) during 1year follow-up
From enrollment to 1year after the procedure
Cardiac mortality
Periodo de tiempo: From enrollment to 1year after the procedure
Cardiac mortality rate(%) during 1year follow-up
From enrollment to 1year after the procedure
Re-hospitalization due to all cause
Periodo de tiempo: From enrollment to 1year after the procedure
All cause re-hospitalization rate(%) during 1year follow-up
From enrollment to 1year after the procedure
Hospitalization due to heart failure
Periodo de tiempo: From enrollment to 1year after the procedure
Hospitalization due to heart failure rate(%) during 1year follow-up
From enrollment to 1year after the procedure
Average heart rate
Periodo de tiempo: From enrollment to 1year after the procedure
Average heart rate(bpm) monitored by the device
From enrollment to 1year after the procedure
Heart rate distribution
Periodo de tiempo: From enrollment to 1year after the procedure
heart rate distribution recorded in CIED (% of total time) 60bpm to 70 70bpm to 80 80bpm to 90 90bpm to 100 over 100bpm
From enrollment to 1year after the procedure
Pacing burden
Periodo de tiempo: From enrollment to 1year after the procedure
Atrial pacing and ventricular pacing burden(%) recorded in CIEDs
From enrollment to 1year after the procedure
Peak oxygen consumption(Peak VO2) and Oxygen consumption at anaerobic threshold(VO2 at AT)
Periodo de tiempo: From enrollment to 1year after the procedure
Peak VO2 and VO2 at AT measured by cardiopulmonary exercise test. Both parameter calculated in mL/kg/min
From enrollment to 1year after the procedure
LV ejection fraction (LVEF)
Periodo de tiempo: From enrollment to 1year after the procedure
LVEF(%) measured by echocardiogram
From enrollment to 1year after the procedure
E/e' ratio measured by echocardiogram
Periodo de tiempo: From enrollment to 1year after the procedure
E/e' ratio, calculated as the ratio of early mitral inflow velocity (E) to early diastolic mitral annular velocity (e'), both velocities measured in m/s.
From enrollment to 1year after the procedure
Cardiac index
Periodo de tiempo: From enrollment to 1year after the procedure
Cardiac index(as L/min/m^2) measured with echocardiogram and body surface area
From enrollment to 1year after the procedure
Peak TR velocity
Periodo de tiempo: From enrollment to 1year after the procedure
Peak TR velocity(TR V max) measured by echocardiogram (m/s)
From enrollment to 1year after the procedure
Left atrial strain
Periodo de tiempo: From enrollment to 1year after the procedure
Left atrial strain(%) measured by echocardiogram
From enrollment to 1year after the procedure
ECG parameters
Periodo de tiempo: From enrollment to 1year after the procedure
QRS duration, QT interval, P wave duration, PR interval (as ms)
From enrollment to 1year after the procedure

Colaboradores e Investigadores

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

Patrocinador

Samsung Medical Center

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 (Actual)

18 de diciembre de 2025

Finalización primaria (Estimado)

31 de diciembre de 2028

Finalización del estudio (Estimado)

31 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

14 de enero de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de abril de 2026

Publicado por primera vez (Actual)

1 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de mayo de 2026

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

28 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • SMC 2025-05-136
  • KCT0010987 (Otro identificador: Korea National Institute of Health)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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

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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