Testing a Higher Pacemaker Rate in Cardiac Amyloidosis
Tests a higher pacemaker heart rate in adults with cardiac amyloidosis who have a pacemaker.
Plain-language title generated from the registry record
Registry title: Increased Pacemaker Lower Rate in ATTR Cardiac Amyloidosis
Key facts
- Where
- Aarhus and Copenhagen, DenmarkSee the 2 sites
Where in Denmark
- Aarhus University HospitalAarhus, DenmarkNo longer taking part
- RigshospitaletCopenhagen, DenmarkNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Skane
- Trial code
- NCT07413081
- Record updated
- 17 February 2026
- Original description
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.Read full original descriptionShow less
Increased Pacemaker Lower Rate in ATTR Cardiac Amyloidosis: a Randomized, Crossover Clinical Trial (PACE-ATTR)
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.
Inclusion: 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).
Exclusion: 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; Enrollment in other interventional device or drug trials during the study period, with the exception of open label extension studies; 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; 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; 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; Listed for cardiac transplantation; Inability to perform the 6-minute walk test; Planned upgrade to CRT or conduction system pacing in patients with RV pacing; More than moderate valvular stenosis or regurgitation.