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

2026년 4월 28일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

106

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 대한민국
    • Seoul
      • Seoul, Seoul, 대한민국, 06351
        • 모병
        • Samsung Medical Center
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
절차: Adjustment of the pacemaker/ICDs lower rate limit (LRL)
Optimized Pacing Strategy
활성 비교기: 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.
절차: Conventional lower rate (60bpm)
Conventional Pacing Strategy

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Kansas City Cardiomyopathy Questionnaire
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
NTproBNP
기간: From enrollment to 1year after the procedure
pg/mL (picograms per milliliter)
From enrollment to 1year after the procedure
Functional status (NYHA class)
기간: 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
기간: From enrollment to 1year after the procedure
m
From enrollment to 1year after the procedure
Occurrence of atrial fibrillation
기간: 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
기간: 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
기간: 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
기간: From enrollment to 1year after the procedure
year
From enrollment to 1year after the procedure
All-cause mortality
기간: From enrollment to 1year after the procedure
All-cause mortality rate(%) during 1year follow-up
From enrollment to 1year after the procedure
Cardiac mortality
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: From enrollment to 1year after the procedure
LVEF(%) measured by echocardiogram
From enrollment to 1year after the procedure
E/e' ratio measured by echocardiogram
기간: 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
기간: 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
기간: 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
기간: From enrollment to 1year after the procedure
Left atrial strain(%) measured by echocardiogram
From enrollment to 1year after the procedure
ECG parameters
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Samsung Medical Center

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 12월 18일

기본 완료 (추정된)

2028년 12월 31일

연구 완료 (추정된)

2028년 12월 31일

연구 등록 날짜

최초 제출

2026년 1월 14일

QC 기준을 충족하는 최초 제출

2026년 4월 28일

처음 게시됨 (실제)

2026년 5월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 28일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SMC 2025-05-136
  • KCT0010987 (기타 식별자: Korea National Institute of Health)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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