Optimal Pacing Rate for Cardiac Resynchronization Therapy

Официальное название

Optimal Pacing Rate for Cardiac Resynchronization Therapy After Atrioventricular Node Ablation in Persistent Atrial Fibrillation and Heart Failure

Обзор

This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test. The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.

Подробное описание

Cardiac resynchronization therapy (CRT) after atrioventricular node (AVN) ablation for permanent atrial fibrillation (AF) has led to better outcomes in heart failure (HF) patients with reduced ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF) compared to pharmacotherapy. Emerging evidence has demonstrated patients with HFpEF may benefit from a higher heart rate compared to standard heart-lowering therapies. The optimal pacing rate for CRT after AVN ablation in persistent AF and HFpEF remains unknown.

This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test.

The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa. Patient mortality and HF hospitalizations will be recorded at each phase. An electrocardiogram, echocardiogram, pacemaker interrogation, BNP and creatinine levels, KCCQ-12, six-minute walk test, and physical activity measure will be obtained at baseline, 3 months, and 6 months.

Вмешательства

• Устройство Pacing rate of 80 bpm
  Pacing rate of 80 bpm
• Устройство Pacing rate of 60 bpm
  Pacing rate of 60 bpm

Первичные конечные точки

• Exercise tolerance as measured by the Six-Minute Walk Test [Срок оценки: 3 months]

Вторичные конечные точки (12)

• Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire [Срок оценки: 3 months]
• Function as measured by the International Physical Activity Questionnaire [Срок оценки: 3 months]
• Change in B-type natriuretic peptide (BNP) [Срок оценки: 3 months]
• Change in creatinine [Срок оценки: 3 months]
• Change in New York Heart Association Class [Срок оценки: 3 months]
• Atrial fibrillation burden [Срок оценки: 3 months]
• Hospitalization for heart failure [Срок оценки: 3 months]
• Death due to heart failure [Срок оценки: 3 months]
• Death due to myocardial infarction [Срок оценки: 3 months]
• Death due to stroke [Срок оценки: 3 months]
• Hospitalization for atrial fibrillation [Срок оценки: 3 months]
• Administration of loop diuretic/anti-arrhythmic drug [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Age 18 years or older
• History of persistent or permanent atrial fibrillation
• Implantation of CRT or conduction system pacing in prior 3 months to 5 years of study start
• History of intrinsic AVN block or have undergone AVN ablation in prior 3 months to 5 years of study start
• LVEF ≥ 50%
• N-terminal pro-B-type natriuretic peptide (NT-proBNP) >400 pg/mL in the last 24 months
• Clinical HF diagnosis or NYHA class II or higher
• Able to provide informed consent

Критерии исключения

• LVEF <50%
• Wide QRS (greater than 150ms)
• Isolated RV pacing
• Severe valvular disease
• Severe coronary artery disease as defined by one of the following:

• ACS or PCI within 1 year
• Any angina (CCS class 1+)
• Unrevascularizable severe CAD (>70% stenosis in 1+ major vessels and/or based on functional assessment)
• ESRD
• Significant primary pulmonary disease on home oxygen
• Major orthopedic issues, such as being wheelchair bound and/or unable to perform a six-minute walk test
• Ventricular ectopy >15% premature ventricular contractions (PVC)
• End stage cancer diagnosis
• Life expectancy less than one year
• Palliative or hospice care
• Hypertrophic cardiomyopathy (HCM)
• Uncorrected ventricular septal defect
• Infiltrative cardiomyopathy (CM)
• Uncontrolled hypertension as defined by blood pressure >160/100 mm Hg on two measurements ≥15 minutes apart
• Hemoglobin <7 g/dL
• Age >90 years old
• Pregnant or intends to become pregnant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 5 центров

• MedStar Georgetown University Hospital — Washington D.C.
• MedStar Washington Hospital Center — Washington D.C.
• MedStar Union Memorial Hospital — Baltimore
• MedStar Southern Maryland Hospital — Clinton
• MedStar Heart and Vascular Office at Fairfax — Fairfax

Публикации

• Czulada E, Smith JD, Kolm P, Deb B, Dolman SF, Alexander N, Braun RA, Kabadi RA, Weintraub WS, Strouse D, Thomaides A. Rationale and Design of OPT-RATE AF: A Randomized Clinical Trial of Increased Physiologic Pacing Rates in Heart Failure With Preserved Ejection Fraction. Am J Cardiol. 2025 Jan 1;234:1-8. doi: 10.1016/j.amjcard.2024.09.033. Epub 2024 Oct 18. PMID 39427696

Идентификаторы

NCT: NCT06445439 · STUDY00006952

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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