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- Essai clinique NCT07563153
Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker (OPTPACE-HF)
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
Statut
Les conditions
Intervention / Traitement
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
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Juwon Kim, MD
- Numéro de téléphone: 82-10-2079-8154
- E-mail: abcd186a@naver.com
Lieux d'étude
-
-
Seoul
-
Seoul, Seoul, Corée du Sud, 06351
- Recrutement
- Samsung Medical Center
-
Contact:
- Juwon Kim, MD
- Numéro de téléphone: 82-2-3410-3419
- E-mail: abcd186a@naver.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
Patients with symptomatic bradycardia who meet the indication for permanent pacemaker implantation and fulfill one of the following conditions:
- Sick sinus syndrome with or without impaired atrioventricular conduction
- Persistent or permanent atrial fibrillation with slow ventricular response
- 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:
- In sinus rhythm: baseline atrial rate > 60 bpm on Holter monitoring or inpatient ECG monitoring
- 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
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
|
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
Parrainer
Publications et liens utiles
Publications générales
- Bohm M, Swedberg K, Komajda M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Heart rate as a risk factor in chronic heart failure (SHIFT): the association between heart rate and outcomes in a randomised placebo-controlled trial. Lancet. 2010 Sep 11;376(9744):886-94. doi: 10.1016/S0140-6736(10)61259-7.
- Bozkurt B, Colvin M, Cook J, Cooper LT, Deswal A, Fonarow GC, Francis GS, Lenihan D, Lewis EF, McNamara DM, Pahl E, Vasan RS, Ramasubbu K, Rasmusson K, Towbin JA, Yancy C; American Heart Association Committee on Heart Failure and Transplantation of the Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; and Council on Quality of Care and Outcomes Research. Current Diagnostic and Treatment Strategies for Specific Dilated Cardiomyopathies: A Scientific Statement From the American Heart Association. Circulation. 2016 Dec 6;134(23):e579-e646. doi: 10.1161/CIR.0000000000000455. Epub 2016 Nov 3. No abstract available.
- van Loon T, Rijks J, van Koll J, Wolffs J, Cornelussen R, van Osta N, Luermans J, Prinzen F, Linz D, van Empel V, Delhaas T, Vernooy K, Lumens J. Accelerated atrial pacing reduces left-heart filling pressure: a combined clinical-computational study. Eur Heart J. 2024 Dec 7;45(46):4953-4964. doi: 10.1093/eurheartj/ehae718.
- Infeld M, Wahlberg K, Cicero J, et al. Effect of Personalized Accelerated Pacing on Quality of Life, Physical Activity, and Atrial Fibrillation in Patients With Preclinical and Overt Heart Failure With Preserved Ejection Fraction: The myPACE Randomized Clinical Trial. JAMA Cardiol 2023; 8(3): 213-21.
- Hernandez AF, Hammill BG, O'Connor CM, Schulman KA, Curtis LH, Fonarow GC. Clinical effectiveness of beta-blockers in heart failure: findings from the OPTIMIZE-HF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure) Registry. J Am Coll Cardiol. 2009 Jan 13;53(2):184-92. doi: 10.1016/j.jacc.2008.09.031.
- Hunt SA, Baker DW, Chin MH, et al. ACC/AHA Guidelines for the Evaluation and Management of Chronic Heart Failure in the Adult: Executive Summary A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1995 Guidelines for the Evaluation and Management of Heart Failure): Developed in Collaboration With the International Society for Heart and Lung Transplantation; Endorsed by the Heart Failure Society of America. Circulation 2001; 104(24): 2996-3007.
- Guidelines for the evaluation and management of heart failure. Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Evaluation and Management of Heart Failure). J Am Coll Cardiol 1995; 26(5): 1376-98
- Wachter R, Schmidt-Schweda S, Westermann D, Post H, Edelmann F, Kasner M, Luers C, Steendijk P, Hasenfuss G, Tschope C, Pieske B. Blunted frequency-dependent upregulation of cardiac output is related to impaired relaxation in diastolic heart failure. Eur Heart J. 2009 Dec;30(24):3027-36. doi: 10.1093/eurheartj/ehp341.
- Kotecha D, Flather MD, Altman DG, Holmes J, Rosano G, Wikstrand J, Packer M, Coats AJS, Manzano L, Bohm M, van Veldhuisen DJ, Andersson B, Wedel H, von Lueder TG, Rigby AS, Hjalmarson A, Kjekshus J, Cleland JGF; Beta-Blockers in Heart Failure Collaborative Group. Heart Rate and Rhythm and the Benefit of Beta-Blockers in Patients With Heart Failure. J Am Coll Cardiol. 2017 Jun 20;69(24):2885-2896. doi: 10.1016/j.jacc.2017.04.001. Epub 2017 Apr 30.
- Nikolovska Vukadinovic A, Vukadinovic D, Borer J, Cowie M, Komajda M, Lainscak M, Swedberg K, Bohm M. Heart rate and its reduction in chronic heart failure and beyond. Eur J Heart Fail. 2017 Oct;19(10):1230-1241. doi: 10.1002/ejhf.902. Epub 2017 Jun 19.
- Writing Committee Members; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. J Card Fail. 2022 May;28(5):e1-e167. doi: 10.1016/j.cardfail.2022.02.010. Epub 2022 Apr 1.
- Lee CJ, Lee H, Yoon M, Chun KH, Kong MG, Jung MH, Kim IC, Cho JY, Kang J, Park JJ, Kim HC, Choi DJ, Lee J, Kang SM. Heart Failure Statistics 2024 Update: A Report From the Korean Society of Heart Failure. Int J Heart Fail. 2024 Apr 18;6(2):56-69. doi: 10.36628/ijhf.2024.0010. eCollection 2024 Apr.
- Masarone D, Ammendola E, Rago A, Gravino R, Salerno G, Rubino M, Marrazzo T, Molino A, Calabro P, Pacileo G, Limongelli G. Management of Bradyarrhythmias in Heart Failure: A Tailored Approach. Adv Exp Med Biol. 2018;1067:255-269. doi: 10.1007/5584_2017_136.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
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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