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| ID | Type | Description | Link |
|---|---|---|---|
| KCT0010987 | Other Identifier | Korea National Institute of Health |
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This study aims to evaluate the clinical impact of an optimized pacing strategy in patients with heart failure.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimized pacing strategy | Experimental | Optimized Pacing Strategy
|
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| Conventional pacing strategy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjustment of the pacemaker/ICDs lower rate limit (LRL) | Procedure | Optimized Pacing Strategy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire | Higher scores indicate better health status and a higher quality of life, score 0 to 100 | From enrollment to 1year after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| NTproBNP | pg/mL (picograms per milliliter) | From enrollment to 1year after the procedure |
| Functional status (NYHA class) | class I to IV, higher NYHA classes indicate poorer functional status. |
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Inclusion Criteria:
Patients with symptomatic bradycardia who meet the indication for permanent pacemaker implantation and fulfill one of the following conditions:
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:
(Sufficient cardiac physiologic pacing is defined as a paced QRS duration ≤ 140 ms.)
Patients not expected to achieve sufficient pacing dependency, defined as:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juwon Kim, MD | Contact | 82-10-2079-8154 | abcd186a@naver.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | Seoul | 06351 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27832612 | Result | 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. | |
| 39589540 |
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| Conventional lower rate (60bpm) | Procedure | Conventional Pacing Strategy |
|
| From enrollment to 1year after the procedure |
| Distance in 6-minute walk test | m | From enrollment to 1year after the procedure |
| Occurrence of atrial fibrillation | Documented incidence of atrial fibrillation on 12-lead ECG | From enrollment to 1year after the procedure |
| Atrial fibrillation burden | Atrial fibrillation burden(%) recorded by CIEDs | From enrollment to 1year after the procedure |
| Invasive hemodynamics parameters in right heart catheterization | 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 | year | From enrollment to 1year after the procedure |
| All-cause mortality | All-cause mortality rate(%) during 1year follow-up | From enrollment to 1year after the procedure |
| Cardiac mortality | Cardiac mortality rate(%) during 1year follow-up | From enrollment to 1year after the procedure |
| Re-hospitalization due to all cause | All cause re-hospitalization rate(%) during 1year follow-up | From enrollment to 1year after the procedure |
| Hospitalization due to heart failure | Hospitalization due to heart failure rate(%) during 1year follow-up | From enrollment to 1year after the procedure |
| Average heart rate | Average heart rate(bpm) monitored by the device | From enrollment to 1year after the procedure |
| Heart rate distribution | 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 | 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) | 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) | LVEF(%) measured by echocardiogram | From enrollment to 1year after the procedure |
| E/e' ratio measured by echocardiogram | 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 | Cardiac index(as L/min/m^2) measured with echocardiogram and body surface area | From enrollment to 1year after the procedure |
| Peak TR velocity | Peak TR velocity(TR V max) measured by echocardiogram (m/s) | From enrollment to 1year after the procedure |
| Left atrial strain | Left atrial strain(%) measured by echocardiogram | From enrollment to 1year after the procedure |
| ECG parameters | QRS duration, QT interval, P wave duration, PR interval (as ms) | From enrollment to 1year after the procedure |
| Result |
| 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. |
| 36723919 | Result | Infeld M, Wahlberg K, Cicero J, Plante TB, Meagher S, Novelli A, Habel N, Krishnan AM, Silverman DN, LeWinter MM, Lustgarten DL, Meyer M. 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 Mar 1;8(3):213-221. doi: 10.1001/jamacardio.2022.5320. |
| 19130987 | Result | 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. |
| 11739319 | Result | Hunt SA, Baker DW, Chin MH, Cinquegrani MP, Feldman AM, Francis GS, Ganiats TG, Goldstein S, Gregoratos G, Jessup ML, Noble RJ, Packer M, Silver MA, Stevenson LW, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Jacobs AK, Hiratzka LF, Russell RO, Smith SC Jr; 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); International Society for Heart and Lung Transplantation; Heart Failure Society of America. 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 Dec 11;104(24):2996-3007. doi: 10.1161/hc4901.102568. No abstract available. |
| 7594057 | Result | 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 Nov 1;26(5):1376-98. No abstract available. |
| 19720638 | Result | 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. |
| 28467883 | Result | 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. |
| 28627045 | Result | 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. |
| 20801495 | Result | 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. |
| 35378257 | Result | 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. |
| 38694933 | Result | 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. |
| 29280096 | Result | 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. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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