Набор скоро начнётся NCT07413081

Increased Pacemaker Lower Rate in ATTR Cardiac Amyloidosis

Без фазы С лечением Cardiac Amyloidosis Pacemaker

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Increasing the pacemaker lower rate, Standard setting.
Кому может быть актуально: Состояния в реестре: Cardiac Amyloidosis, Pacemaker. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Дания, Швеция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Increased Pacemaker Lower Rate in ATTR Cardiac Amyloidosis: a Randomized, Crossover Clinical Trial (PACE-ATTR)

Обзор

In cardiac amyloidosis, the heart muscle becomes thick and stiff, making it difficult to pump enough blood with each beat. The heart also often cannot increase its stroke volume, making patients with cardiac amyloidosis more dependent on having an adequate heart rate. Many develop conduction problems and need a pacemaker. In a related condition, heart failure with preserved ejection fraction, setting a higher pacemaker rate improved patients' quality of life. It is not known if the same benefits apply to amyloidosis. This study will test whether raising the pacemaker rate improves well-being and daily function in affected patients.

Подробное описание

Transthyretin amyloid cardiomyopathy (ATTR-CM) is an increasingly recognized cause of restrictive cardiomyopathy, characterized by reduced ventricular compliance, low stroke volume, and marked dependence on heart rate for maintenance of cardiac output. Conduction disease is common in ATTR-CM, and a substantial proportion of patients require permanent pacemaker implantation.

Although disease-modifying therapy can slow disease progression, evidence guiding optimization of pacemaker therapy in ATTR-CM is lacking. In heart failure with preserved ejection fraction, a condition also characterized by reduced ventricular compliance, increased pacemaker lower rate settings have been shown to improve functional capacity and quality of life. However, patients with cardiac amyloidosis were excluded from these studies. Consequently, current practice in ATTR-CM relies largely on extrapolation and expert opinion.

In this randomized multicenter 2×2 crossover trial, we aim to determine whether a higher pacemaker lower rate (80 bpm) improves health-related quality of life (QoL) and functional capacity in patients with ATTR-CM compared with the standard setting of 60 bpm.

Вмешательства

Устройство Increasing the pacemaker lower rate
Increasing the pacemaker lower rate from 60 to 80 bpm
Устройство Standard setting
Lower rate setting of 60 bpm

Первичные конечные точки

Minnesota Living with Heart Failure Questionnaire (MLHFQ) [Срок оценки: End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)]

Вторичные конечные точки (8)

Distance walked during the 6-Minute Walk Test (6MWT) [Срок оценки: End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)]
Levels of N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) [Срок оценки: End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)]
New York Heart Association (NYHA) Functional Class [Срок оценки: End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)]
National Amyloidosis Centre (NAC) Stage [Срок оценки: End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)]
Number of participants with hospitalization or urgent outpatient visit for atrial fibrillation [Срок оценки: During each treatment period (approximately 3 months per period)]
Atrial fibrillation burden assessed by implanted pacemaker [Срок оценки: During each treatment period (approximately 3 months per period)]
Physical activity level assessed by implanted pacemaker [Срок оценки: During each treatment period (approximately 3 months per period)]
Levels of High-Sensitivity Cardiac Troponin (hs-cTn) [Срок оценки: End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)]

Критерии участия

Критерии включения

ATTR-CM defined as one of the following:
a.Positive cardiac biopsy for ATTR amyloidosis
b.Positive extra-cardiac biopsy for ATTR amyloidosis AND cardiac involvement demonstrated by CMR or echocardiography
c.Grade 2-3 uptake on DPD-scintigraphy AND negative serum free light chain and negative urine and serum immunofixation AND cardiac involvement demonstrated by CMR or echocardiography
Ongoing treatment with a transthyretin stabilizer or silencer OR considered not to be a candidate for these therapies with no planned initiation during the study period.
NYHA functional class II-III
Pre-existing pacemaker and either:
a.Atrial pacing with minimal RV pacing (<2%), or
b.His bundle or left bundle branch area pacing, or
c.Biventricular pacing, or
d.Ongoing RV pacing with a high degree of RV pace (>80%)
NT-proBNP >600 ng/L
Age ≥18 years
Ability and willingness to provide written informed consent
Pacing >80% with a programmed lower rate of 60 (AAI/CSP/CRT/RV-pace)

Критерии исключения

Inability to perform the 6-minute walk test.
Planned coronary revascularization, ablation of atrial flutter/fibrillation, or any severe (obstructive or regurgitant) valvular heart disease expected to require intervention during the trial in the investigator's opinion.
MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, cardioversion, valve repair/replacement, hospitalization for decompensated heart failure or cardiac resynchronisation therapy within 12 weeks prior to enrollment.
Planned upgrade to CRT or conduction system pacing in patients with RV pacing.
More than moderate valvular stenosis or regurgitation
Inability of the patient, in the opinion of the investigator, to understand and/or comply with procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
Presence of any other disease than heart failure with a life expectancy of < 1year in the investigators opinion
Enrollment in other interventional device or drug trials during the study period, with the exception of open label extension studies
Listed for cardiac transplantation
Initiation of SGLT2-inhibitor or mineralocorticoid receptor antagonist within 4 weeks prior to enrollment
Initiation or change in loop diuretic therapy within 4 weeks prior to enrollment

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

Здоровые добровольцы: Нет