Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker

NCT07563153 | Recruiting

• 2 other identifiers: SMC 2025-05-136KCT0010987
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Bradycardia

Keywords

Heart failure; bradycardia; CIED; lower rate

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (21)

• NTproBNP

  From enrollment to 1year after the procedure

• Functional status (NYHA class)

  From enrollment to 1year after the procedure

• Distance in 6-minute walk test

  From enrollment to 1year after the procedure

• Occurrence of atrial fibrillation

  From enrollment to 1year after the procedure

• Atrial fibrillation burden

  From enrollment to 1year after the procedure

Study Arms (2)

Optimized pacing strategy

EXPERIMENTAL

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.

Procedure: Adjustment of the pacemaker/ICDs lower rate limit (LRL)

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.

Procedure: Conventional lower rate (60bpm)

Interventions

Adjustment of the pacemaker/ICDs lower rate limit (LRL) PROCEDURE

Optimized Pacing Strategy

Optimized pacing strategy

Conventional lower rate (60bpm) PROCEDURE

Conventional Pacing Strategy

Conventional pacing strategy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

RECRUITING

Related Publications (13)

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  PMID: 27832612 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.

  PMID: 39589540 RESULT

• 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.

  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.

  PMID: 19130987 RESULT

• 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.

  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; 26(5): 1376-98

  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.

  PMID: 19720638 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.

  PMID: 28467883 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.

  PMID: 28627045 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.

  PMID: 20801495 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.

  PMID: 35378257 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.

  PMID: 38694933 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.

  PMID: 29280096 RESULT

MeSH Terms

Conditions

Heart Failure; Bradycardia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Juwon Kim, MD

CONTACT

82-10-2079-8154; abcd186a@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assitant Professor

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: May 1, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)