PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
The PEP-HFpEF study is a prospective, single-center mechanistic study evaluating personalized heart rate pacing (myPACE) in patients with heart failure with preserved ejection fraction (HFpEF) and existing cardiac physiologic pacemakers. Participants will undergo sequential periods of standard and personalized pacing with serial physiologic assessments to evaluate the effects of myPACE on exercise capacity, cardiac function, biomarkers, quality of life, and clinical outcomes.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Courtney Uek
- 電話番号：617-636-4354
- メール：courtney.uek@tuftsmedicine.org
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02111
- 募集
- Tufts Medical Center
-
コンタクト：
- Courtney Uek
- 電話番号：617-636-4354
- メール：courtney.uek@tuftsmedicine.org
-
コンタクト：
-
主任研究者：
- Margaret Infeld, MD, MS
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age ≥18 years.
- Diagnosis of heart failure with preserved ejection fraction (HFpEF), defined as left ventricular ejection fraction (LVEF) ≥50% with symptoms and signs consistent with heart failure as determined by the treating investigator.
- New York Heart Association (NYHA) Class II or III symptoms despite stable, maximally tolerated guideline-directed medical therapy.
- Pre-existing FDA-approved cardiac physiologic pacemaker (e.g., conduction system pacing or cardiac resynchronization therapy) implanted for a standard clinical indication and capable of individualized lower-rate programming.
- Expected to require ongoing pacemaker therapy throughout the study period.
- Clinically stable at enrollment, without recent major changes in heart failure status that, in the opinion of the investigator, would interfere with interpretation of study outcomes.
- Able and willing to provide written informed consent.
- Able and willing to comply with all study procedures, including pacemaker programming, cardiopulmonary exercise testing (CPET), echocardiography, blood pressure measurements, autonomic testing, blood collection, and follow-up visits.
Exclusion Criteria:
- Age <18 years.
- Left ventricular ejection fraction <50%.
- Pregnancy, breastfeeding, or women of childbearing potential unwilling to use an acceptable method of contraception during study participation.
- Inability or unwillingness to provide informed consent.
- Inability to safely perform study procedures, including CPET or autonomic testing, in the opinion of the investigator.
- Any medical condition or life expectancy that, in the opinion of the investigator, would make participation unsafe or would substantially interfere with completion of the study or interpretation of study results.
- Enrollment in another interventional clinical trial that, in the opinion of the investigators, could interfere with this study or confound interpretation of the results.
- Prisoners, wards of the state, or other individuals for whom participation would not be permissible under applicable regulations or institutional policy.
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- 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：Individualized myPACE Pacing
Participants will undergo a 3-month baseline period with their pacemaker programmed to standard-of-care settings (lower rate limit of 60 beats per minute), followed by individualized programming using the myPACE heart-rate algorithm for 12 months. Following completion of the 12-month intervention period, pacemakers will be reprogrammed to standard-of-care settings (60 bpm) for an additional 3 months. Participants will undergo study assessments and monitoring throughout the entire 18-month study period. |
The myPACE intervention uses an individualized heart-rate algorithm to determine a personalized pacemaker backup rate within the normal range of adult resting heart rates. The algorithm estimates an individualized resting heart rate based on participant height and left ventricular ejection fraction (LVEF). The algorithm is designed to provide a modest increase in resting heart rate tailored to individual physiologic characteristics, including LVEF. |
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 |
|---|---|---|
|
Peak Oxygen Consumption (Peak VO₂)
時間枠：Baseline, 12 months
|
Change in peak oxygen consumption (peak VO2) during upright bicycle cardiopulmonary exercise testing (CPET), from conventional 60 bpm pacing (at baseline) to personalized physiologic pacing (myPACE) (at 12 months). Peak VO2 will be measured in mL/kg/min. |
Baseline, 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Ventilatory Efficiency (VE/VCO₂ Slope)
時間枠：Baseline, 12 months
|
Change in the VE/VCO₂ slope during upright bicycle CPET from conventional pacing at 60 bpm to personalized physiologic pacing (myPACE). |
Baseline, 12 months
|
|
Oxygen Pulse
時間枠：Baseline, 12 months
|
Change in oxygen pulse during upright bicycle CPET from conventional pacing at 60 bpm to personalized physiologic pacing (myPACE), measured in mL/beat. |
Baseline, 12 months
|
|
Arterial Elastance (Ea)
時間枠：Baseline, 12 months
|
Change in arterial elastance (Ea), measured in mmHg/mL, calculated from echocardiographic measurements and non-invasive blood pressure measurements, from conventional pacing at 60 bpm at baseline to personalized physiologic pacing (myPACE) at 12 months. |
Baseline, 12 months
|
|
End-Systolic Elastance (Ees)
時間枠：Baseline, 12 months
|
Change in end-systolic elastance (Ees), measured in mmHg/mL, calculated from echocardiographic measurements and non-invasive blood pressure measurements, from conventional pacing at 60 bpm at baseline to personalized physiologic pacing (myPACE) at 12 months. |
Baseline, 12 months
|
|
Ventriculo-Arterial Coupling (Ea/Ees Ratio)
時間枠：Baseline, 12 months
|
Change in the Ea/Ees ratio, calculated from arterial elastance (Ea) and end-systolic elastance (Ees), from conventional pacing at 60 bpm at baseline to personalized physiologic pacing (myPACE) at 12 months. |
Baseline, 12 months
|
|
Low-Frequency Blood Pressure Variability
時間枠：Baseline, 12 months
|
Change in low-frequency blood-pressure variability during standardized autonomic nervous system testing from conventional pacing at 60 bpm at baseline to personalized physiologic pacing (myPACE) at 12 months. |
Baseline, 12 months
|
|
Orthostatic Blood Pressure Recovery
時間枠：Baseline, 12 months
|
Change in orthostatic blood pressure recovery during standardized autonomic nervous system testing from conventional pacing at 60 bpm at baseline to personalized physiologic pacing (myPACE) at 12 months. |
Baseline, 12 months
|
|
Passive Leg Raise Response
時間枠：Baseline, 12 months
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Change in the passive-leg-raise response during standardized autonomic nervous system testing from conventional pacing at 60 bpm at baseline to personalized physiologic pacing (myPACE) at 12 months. |
Baseline, 12 months
|
|
NTproBNP
時間枠：Baseline, 6 months, 12 months, 15 months
|
NTproBNP level change from baseline to 12 months |
Baseline, 6 months, 12 months, 15 months
|
|
Minnesota Living with Heart Failure Questionnaire Score
時間枠：Baseline, 12 months
|
Change in total score on the Minnesota Living with Heart Failure Questionnaire (MLHFQ), a 21-item questionnaire assessing the impact of heart failure on health-related quality of life. The total score ranges from 0 to 105, with higher scores indicating worse health-related quality of life and greater impairment. Change in total score will be assessed from baseline to 12 months to evaluate the effect of personalized physiologic pacing compared with conventional pacing at 60 beats per minute. |
Baseline, 12 months
|
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Hospitalization or Invasive Outpatient Intervention for Heart Failure
時間枠：Through 18 months
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Throughout the duration of the study the study team will review intercurrent clinical management events that may occur as part of the natural history and clinical management of HFpEF, including hospitalization or invasive outpatient intervention for heart failure. |
Through 18 months
|
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Heart Failure Management Events
時間枠：Through 18 months
|
Changes in heart failure management, including diuretic initiation, dose escalation, reduction, or discontinuation, and urgent medical visits for heart failure. Clinical events will be assessed through participant interviews and medical record review throughout study participation and formally assessed during each follow-up Assessment Window. |
Through 18 months
|
|
Abnormal Heart Rhythm Management Events
時間枠：Through 18 months
|
Throughout the duration of the study the study team will record changes in abnormal heart rhythm management, including initiation of antiarrhythmic medication, cardioversion, ablation, urgent medical visits for abnormal heart rhythms, or hospitalization for abnormal heart rhythms. Clinical events will be assessed through participant interviews and medical record review throughout study participation and formally assessed during each follow-up Assessment Window. |
Through 18 months
|
|
Serious Cardiovascular Events
時間枠：Through 18 months
|
Throughout the duration of the study the study team will review serious cardiovascular events, including heart attack, stroke, or death. Clinical events will be assessed through participant interviews and medical record review throughout study participation and formally assessed during each follow-up Assessment Window. |
Through 18 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Margaret Infeld, MD, MS、Tufts Medical Center
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY00007273: PEP-HFpEF
- 26CDA1621876 (その他の助成金/資金番号：American Heart Association)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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