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Starting soon Not applicable

Increased Pacemaker Lower Rate in ATTR Cardiac Amyloidosis

NCT07413081 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2026-02-01
Last updated
2026-02-17

Condition(s) studied

Cardiac AmyloidosisPacemaker

Investigational drug(s) / intervention(s)

Increasing the pacemaker lower rateStandard setting

Increasing the pacemaker lower rate: Increasing the pacemaker lower rate from 60 to 80 bpm

Standard setting: Lower rate setting of 60 bpm

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

  • Minnesota Living with Heart Failure Questionnaire (MLHFQ) — End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)
    The MLHFQ is a validated patient-reported outcome assessing heart failure-related quality of life. It consists of 21 items scored 0-5, yielding a total score range of 0-105. Higher scores indicate worse quality of life. MLHFQ is collected at Visits 1-4.

Trial sites (9)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Sahlgrenska University Hospital Gothenburg Sweden
Linköping University Hospital Linköping Sweden
Skane University Hospital Lund Sweden
Skellefteå Hospital Skellefteå Sweden
Karolinska University Hospital Stockholm Sweden
Norrland University Hospital Umeå Sweden
Academic University Hospital Uppsala Sweden

More Region Skane trials in Denmark

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07413081 on ClinicalTrials.gov ↗ ← All trials in Denmark