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

2026年4月28日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

106

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 韓国
    • Seoul
      • Seoul、Seoul、韓国、06351
        • 募集
        • Samsung Medical Center
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
手順：Adjustment of the pacemaker/ICDs lower rate limit (LRL)
Optimized Pacing Strategy
アクティブコンパレータ：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.
手順：Conventional lower rate (60bpm)
Conventional Pacing Strategy

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Kansas City Cardiomyopathy Questionnaire
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
NTproBNP
時間枠：From enrollment to 1year after the procedure
pg/mL (picograms per milliliter)
From enrollment to 1year after the procedure
Functional status (NYHA class)
時間枠：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
時間枠：From enrollment to 1year after the procedure
m
From enrollment to 1year after the procedure
Occurrence of atrial fibrillation
時間枠：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
時間枠：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
時間枠：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
時間枠：From enrollment to 1year after the procedure
year
From enrollment to 1year after the procedure
All-cause mortality
時間枠：From enrollment to 1year after the procedure
All-cause mortality rate(%) during 1year follow-up
From enrollment to 1year after the procedure
Cardiac mortality
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：From enrollment to 1year after the procedure
LVEF(%) measured by echocardiogram
From enrollment to 1year after the procedure
E/e' ratio measured by echocardiogram
時間枠：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
時間枠：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
時間枠：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
時間枠：From enrollment to 1year after the procedure
Left atrial strain(%) measured by echocardiogram
From enrollment to 1year after the procedure
ECG parameters
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Samsung Medical Center

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年12月18日

一次修了 (推定)

2028年12月31日

研究の完了 (推定)

2028年12月31日

試験登録日

最初に提出

2026年1月14日

QC基準を満たした最初の提出物

2026年4月28日

最初の投稿 (実際)

2026年5月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月1日

QC基準を満たした最後の更新が送信されました

2026年4月28日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • SMC 2025-05-136
  • KCT0010987 (その他の識別子：Korea National Institute of Health)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

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いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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