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Heart FailureOPTPACE-HFNCT07563153

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

A study testing Adjustment of the pacemaker/ICDs lower rate limit (LRL) and Conventional lower rate (60bpm) in people with Heart Failure and Bradycardia, run by Samsung Medical Center at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Heart Failure, Bradycardia
What is being tested?
Adjustment of the pacemaker/ICDs lower rate limit (LRL) and Conventional lower rate (60bpm)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteSouth Korea
Study dates
18 Dec 2025to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Juwon Kim, MD contact

82-10-2079-8154

abcd186a@naver.com

South Korea1 site, 1 recruiting

  • Samsung Medical Center

    Seoul, Seoul, 06351

    Juwon Kim, MD, 82-2-3410-3419, abcd186a@naver.com

    Recruiting

Other trials in South Korea

About this study

Official title: 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.
Read the detailed description

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.

Being tested
Adjustment of the pacemaker/ICDs lower rate limit (LRL), Conventional lower rate (60bpm)
Keywords
Heart failure, bradycardia, CIED, lower rate
Medical subject headings
Heart Failure, Bradycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjustment of the pacemaker/ICDs lower rate limit (LRL)Procedure or surgery

    Optimized Pacing Strategy

  • Conventional lower rate (60bpm)Procedure or surgery

    Conventional Pacing Strategy

Study groups in NCT07563153
Study groupRoleWhat they receive
Optimized pacing strategyExperimentalOptimized 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.
Receives: Procedure: Adjustment of the pacemaker/ICDs lower rate limit (LRL)
Conventional pacing strategyActive comparatorConventional 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.
Receives: Procedure: Conventional lower rate (60bpm)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kansas City Cardiomyopathy Questionnaire

    Higher scores indicate better health status and a higher quality of life, score 0 to 100

    Measured: From enrollment to 1year after the procedure

Secondary outcomes (21)

  1. NTproBNP

    pg/mL (picograms per milliliter)

    Measured: From enrollment to 1year after the procedure

  2. Functional status (NYHA class)

    class I to IV, higher NYHA classes indicate poorer functional status.

    Measured: From enrollment to 1year after the procedure

  3. Distance in 6-minute walk test

    m

    Measured: From enrollment to 1year after the procedure

  4. Occurrence of atrial fibrillation

    Documented incidence of atrial fibrillation on 12-lead ECG

    Measured: From enrollment to 1year after the procedure

  5. Atrial fibrillation burden

    Atrial fibrillation burden(%) recorded by CIEDs

    Measured: From enrollment to 1year after the procedure

  6. Invasive hemodynamics parameters in right heart catheterization

    pressure of RA, RV, PA, PCWP as mmHg Cardiac output as L/min (Liters per minute)

    Measured: At the time of CIED implantation

  7. CIED Battery longevity

    year

    Measured: From enrollment to 1year after the procedure

  8. All-cause mortality

    All-cause mortality rate(%) during 1year follow-up

    Measured: From enrollment to 1year after the procedure

  9. Cardiac mortality

    Cardiac mortality rate(%) during 1year follow-up

    Measured: From enrollment to 1year after the procedure

  10. Re-hospitalization due to all cause

    All cause re-hospitalization rate(%) during 1year follow-up

    Measured: From enrollment to 1year after the procedure

  11. Hospitalization due to heart failure

    Hospitalization due to heart failure rate(%) during 1year follow-up

    Measured: From enrollment to 1year after the procedure

  12. Average heart rate

    Average heart rate(bpm) monitored by the device

    Measured: From enrollment to 1year after the procedure

  13. 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

    Measured: From enrollment to 1year after the procedure

  14. Pacing burden

    Atrial pacing and ventricular pacing burden(%) recorded in CIEDs

    Measured: From enrollment to 1year after the procedure

  15. 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

    Measured: From enrollment to 1year after the procedure

  16. LV ejection fraction (LVEF)

    LVEF(%) measured by echocardiogram

    Measured: From enrollment to 1year after the procedure

  17. 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.

    Measured: From enrollment to 1year after the procedure

  18. Cardiac index

    Cardiac index(as L/min/m^2) measured with echocardiogram and body surface area

    Measured: From enrollment to 1year after the procedure

  19. Peak TR velocity

    Peak TR velocity(TR V max) measured by echocardiogram (m/s)

    Measured: From enrollment to 1year after the procedure

  20. Left atrial strain

    Left atrial strain(%) measured by echocardiogram

    Measured: From enrollment to 1year after the procedure

  21. ECG parameters

    QRS duration, QT interval, P wave duration, PR interval (as ms)

    Measured: From enrollment to 1year after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2026
  2. Study start18 Dec 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07563153
Sponsor's protocol ID
SMC 2025-05-136
Other IDs
KCT0010987
Acronym
OPTPACE-HF
Status last verified
Apr 2026
First submitted
14 Jan 2026
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27832612

  • 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.

    PubMed 39589540

  • 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.

    PubMed 36723919

  • 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.

    PubMed 19130987

  • 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.

    PubMed 11739319

  • 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.

    PubMed 7594057

  • 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.

    PubMed 19720638

  • 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.

    PubMed 28467883

  • 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.

    PubMed 28627045

  • 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.

    PubMed 20801495

  • 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.

    PubMed 35378257

  • 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.

    PubMed 38694933

  • 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.

    PubMed 29280096

Questions about this trial

What is this clinical trial studying?

A study testing Adjustment of the pacemaker/ICDs lower rate limit (LRL) and Conventional lower rate (60bpm) in people with Heart Failure and Bradycardia, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Juwon Kim, MD (82-10-2079-8154, abcd186a@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kansas City Cardiomyopathy Questionnaire (time frame: From enrollment to 1year after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07563153, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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