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

28 avril 2026 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

106

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

    • Seoul
      • Seoul, Seoul, Corée du Sud, 06351
        • Recrutement
        • Samsung Medical Center
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Optimized Pacing Strategy
Comparateur actif: 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.

Conventional Pacing Strategy

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Kansas City Cardiomyopathy Questionnaire
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
NTproBNP
Délai: From enrollment to 1year after the procedure
pg/mL (picograms per milliliter)
From enrollment to 1year after the procedure
Functional status (NYHA class)
Délai: 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
Délai: From enrollment to 1year after the procedure
m
From enrollment to 1year after the procedure
Occurrence of atrial fibrillation
Délai: 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
Délai: 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
Délai: 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
Délai: From enrollment to 1year after the procedure
year
From enrollment to 1year after the procedure
All-cause mortality
Délai: From enrollment to 1year after the procedure
All-cause mortality rate(%) during 1year follow-up
From enrollment to 1year after the procedure
Cardiac mortality
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: From enrollment to 1year after the procedure
LVEF(%) measured by echocardiogram
From enrollment to 1year after the procedure
E/e' ratio measured by echocardiogram
Délai: 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
Délai: 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
Délai: 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
Délai: From enrollment to 1year after the procedure
Left atrial strain(%) measured by echocardiogram
From enrollment to 1year after the procedure
ECG parameters
Délai: 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

Collaborateurs et enquêteurs

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Publications et liens utiles

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Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 décembre 2025

Achèvement primaire (Estimé)

31 décembre 2028

Achèvement de l'étude (Estimé)

31 décembre 2028

Dates d'inscription aux études

Première soumission

14 janvier 2026

Première soumission répondant aux critères de contrôle qualité

28 avril 2026

Première publication (Réel)

1 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • SMC 2025-05-136
  • KCT0010987 (Autre identifiant: Korea National Institute of Health)

Plan pour les données individuelles des participants (IPD)

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Informations sur les médicaments et les dispositifs, documents d'étude

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Étudie un produit d'appareil réglementé par la FDA américaine

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